E-Served: May 1 2020 PDT Via Case Anywhere EXHIBIT ANNE HOLLAND SECOND CORRECTED EXPERT REPORT I. QUALIFICATIONS As a Biomedical Engineer and Quality Assurance Consultant, I focus exclusively on medical devices. My career includes extensive experience with permanently implantable devices, as well as reusable devices and disposable devices. My areas of expertise include risk management, design controls, quality system development, auditing, post market surveillance and manufacturing process optimization. I received a Bachelor of Science in Biomedical Engineering from Vanderbilt University in I 985, and a Master of Business Administration from the University of Colorado in 1991. I currently hold certifications as a Certified Quality Auditor, Certified Quality Engineer, and Certified Manager of Quality/ Organizational Excellence through the American Society for Quality, Lead Auditor in the qualification-based Quality Management System Auditor Program through Exemplar Global, and Registered Quality Assurance Professional in Good Laboratory Practices through the Society of Quality Assurance. I am a Senior Member and served as Chair of the Austin Section of the American Society for Quality in 2004-2005. In addition to the American Society for Quality, I am a member of the American Society for the Advancement of Medical Instrumentation, Regulatory Affairs Professional Society, and the Society of Quality Assurance. I have experience as an Adjunct Professor at The National Graduate School teaching a graduate course on the Cost of Quality and have also taught Quality Engineering at Austin Community College. I have guest lectured at universities and industry seminars on topics such as design controls, risk management and process validation. In 2000, I founded QA Consulting, Inc. where I continue to serve as CEO. I consult with medical device manufacturers to develop and implement compliant solutions for their quality practices. I have completed over 100 supply chain and internal audits to U. S and International Standards since 2005. While the 510k process is not part of this report, I have been involved in over 30 FDA 510k premarket notification applications and am familiar with the requirements relating to FDA clearance of a medical device. The process described herein focuses on post-market requirements that medical device companies must follow in selling a safe device for the lifetime of that product. Since founding QA Consulting, my experience includes bringing clients into compliance with receiving and investigating complaints, evaluating complaint reportability, regulatory reporting of complaints, and handling routine post-market requirements such as clinical evaluation reports. I have also guided medical device companies in post-market activities including initiating and handling corrective and preventive actions (CAPAs), on-site assistance in FDA inspections, and leading remediation efforts to respond to FDA 483 observations and/or Warning Letters. Prior to creating my company, I held the positions of Senior Manufacturing Engineer, QA Manager, and Senior Quality Assurance Engineer over the course of six (6) years with Sulzer Carbomedics of Austin, TX. Prior to those positions, I served as Project Manager and Design Assurance Engineer with Ohmeda Monitoring, Quality Assurance Project Engineer with Cobe BCT, Inc., Quality Assurance Engineer with Fischer Imaging Corporation, and Project Engineer with LA BAC Medical Systems. My nearly 3 5 years of experience as a Biomedical Engineer in quality assurance, ranges from design concept and research and development, through manufacturing/production and post-market surveillance for Class I, II, and III medical devices. The breadth of experience has afforded me expert knowledge of medical device industry regulations and standards, including but not limited to Title 21 - Food and Drugs of the Code of Federal Regulations, particularly Section 820, Quality System Regulation, with a strong focus in Section 820.198 Complaint files, Section 803, Medical Device Reporting and Section 58, Good Laboratory Practice for Nonclinical Laboratory Studies. I also have in depth knowledge ofISO Standard 13485, Medical Devices - Quality management systems - Requirements for regulatory purposes, and EN ISO 14971, Medical Devices. My current curriculum vitae is attached to this report. II. BACKGROUND I have been asked to review and analyze the complaint handling procedures, policies, and practices for the Essure® System, which is a permanent implant medical device 1 designed to be permanently implanted into a woman for permanent sterilization. The Essure® System is a kit which includes the Essure® micro-insert and Essure® delivery system. The permanent implant is intended to be placed into both fallopian tubes through the cervix using the disposable Essure® delivery system, which includes a delivery catheter. As a class III medical device, it is subject to post-market FDA regulations and medical device reporting requirements. The purpose of the review was to assess the post-market regulatory compliance of the manufacturers' complaint handing system for the Essure® device. Specifically, I was asked to review the manufacturers' compliance with 21 CFR §820.198 et seq. to determine whether the 1 If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration {FDA) as a medical device and is subject to premarketing and post-marketing regulatory controls. A device is: • "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended pmposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended pmposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended pmposes. The term "device" does not include software functions excluded pursuant to section 520(0). 2 manufacturers were complying with the FDA requirements for investigating complaints that it received that alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the Essure® device after it was released for distribution. I was also asked to review the manufacturers' compliance with 21 CFR § 803 et seq. to determine whether the manufacturers were complying with the attendant FDA requirements for reporting Medical Device Reports (MDRs). Essure® is a class III medical device that was approved for sale on November 4, 2002. The primary responsibility for timely communicating complete, accurate, and current safety and efficacy information related to a medical device resides with the manufacturer. To fulfill this essential responsibility, a manufacturer must actively monitor reasonably available information. The manufacturer must evaluate the post-market experience with the device, its components, and accessories and provide updated safety and efficacy information to the Food and Drug Administration (FDA). The specific requirements for managing complaints and reporting adverse events and potential adverse events are primarily governed by FDA regulations 21 CFR 820.198 and 21 CPR 803. The Plaintiffs requested over 45,000 safety related complaints from manufacturers for review. I was asked to review complaints between and including January 1, 2002 and December 31, 2015. Of the complaints provided by the manufacturers, 34,770 unique complaints were associated with an aware date in years 2002-2015. These complaints were sampled in accordance with FDA sampling methods to determine rates of compliance with the applicable regulations with 95% confidence the true value would fall within +/-5% of the sampled value. With the exception of 2002 (in which only 86 unique files were available and all 86 were sampled), 392 complaint files were sampled for each year from 2003-2015, resulting in a total sample size of 5,182. A systematic analysis was performed over a period of months by me and two other complaint experts and our teams. We reviewed complaints according to an established protocol for compliance with the receipt, evaluation, investigation, documentation, MDR reporting, and timeliness requirements of FDA regulations 21 CFR 820.198 and 21 CFR 803. The complaint review analysis resulted in numerous findings enumerated below. In the course of the review of this case, I analyzed, reviewed, and/or relied upon the following categories of information, listings of which are provided with this report: (a) applicable regulatory standards and guidance documents; (b) the manufacturers' internal standard operating procedures, technical documents, and work instructions; ( c) Deposition transcripts of the manufacturers' employees as well as other industry experts; (d) Spreadsheets of the internal complaint handling databases and approximately 45,000 individual complaint files. All of my opinions expressed in this report are offered to a reasonable degree of professional certainty within my field . 3 III. SUMMARY OF OPINIONS AND CONCLUSIONS Based upon my review ofthe documents, including the complaint records sampled, as well as my knowledge and experience, I have formed the opinions and conclusions summarized below. They are discussed in more detaii in the subsequent sections of this report. Overall, the manufacturers consistently failed to comply with FDA requirements for complaint handling and Medical Device Reporting. I identified multiple violations of these FDA regulations. The FDA QSIT Manual reinforces the premise herein, that there are no "acceptable" violations of the Quality System Regulations. 2 The manufacturers failed to comply with 21CFR 820.J(b), Complaint Definition and 21CFR 820.198{a), Complaint Files (Complaint Procedures) in that: • The manufacturers failed to consistently execute a complaint management process that handled any written, electronic, or oral communication that alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution as defined by 21CFR820.3 (b). 3 o Events that met the FDA' s definition of a complaint were not always treated as a complaint per the manufacturers' internal policies.4 At certain times, the Conceptus procedure, SOP-16305 inappropriately categorized reported events as procedural observations which were not handled as complaints or investigated. Additionally, SOP-163 0 6 later modified the complaint definition to include only those events that involved the Essure® device (e.g. micro-insert). Meaning, events related to the Essure® device system (outside of the micro-insert such as the deployment system), implantation procedure, and accessories needed to implant the Essure® micro-insert, the labeling, or the training provided to the users as defined in the PreMarket Approval of the Essure® device were not considered a complaint in violation of 21 CFR820.198( a). o 2 QSIT Manual, 3 The manufacturers approach to complaint handling was not patient-centric, e.g. did not first consider the health and safety of the patient. For example: patients were 'consumers' not 'patients.' There was also a period oftime in which patient reports Quality System Inspection Technique, Guide to Inspections of Quality Systems, August 1999, Note A 21 CFR ~20.3 4 Section VII B i Gap I BAY-JCCP-0062921. Detailed in Section 7 Gap Analysis 6 BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-0063251; BAY-JCCP-0062986; BAY-JCCP0063000; BAY-JCCP-0448852; BAY-JCCP-0208840; BAY-JCCP-0208865; BAY-JCCP-1064506; BAY-JCCP-0216249; BAYJCCP-0210778; 5 4 of events alleging deficiencies related to the Essure® device or their experience with the Essure® device were considered an wiconfirmed event wiless a clinician confirmed the event or the device was returned to the manufacturer and a defect was noted during the returned device investigation; and attempts to collect a full widerstanding of the nature and details of the event or an update on the status of the patient's health were limited or non-existent.7 o The manufacturers' typical approach to complaint handling presumed the Essure® product and associated accessories and labeling were faultless until proven otherwise. The level to prove fault required by the manufacturers was difficult to achieve. Depending upon the year in question the manufacturer required a clinical resource to agree with or confirm the event, they required clinical confirmation of a patient reported condition, or they required the device to be returned and fowid non-compliant. During our review, 3,824 of 5,182 (or 73.8%) of complaints sampled had an inadequate, incorrect, or not documented (missing) rationale regarding the decision to report or not report the event to the FDA as an MOR. ~ o During the review of complaint files, the manufacturers made statements to the complainants (clinicians or patients) in response to received complaints that did not have adequate data to support the statement. For example: • o 7 8 The manufacturer letter to the complainant associated with complaint #AR03949-ZV85 included a statement that there were no confirmed true device failures resulting in pregnancies as of 4/22/08. This is incorrect based upon my review of earlier complaint files. Based upon my review of the complaint files, the depth and breadth of investigations and the quality of the complaint files created and maintained by Conceptus declined beginning in 2003. This conclusion is further supported by the organizational and procedural changes made by Conceptus over time, as evidenced in the following graph: Section VII B iii Gap 2 Table 16 Records with Missing Content by Content Type 5 tfll t 'I _, ' ..... ~ j,.M .~· ...,.. .~. .. , ~ · ;. ~ ~- _ ; • < ,0 . . ' - ' - ...__. Figure 1 Sample Records with No Violation Issues Identified During Review o The transition from Conceptus complaint management process to Bayer' s pharmaceutical based complaint management moved the process from a single organization and record database to multiple organizations and electronic systems, making the process more complex.9 The multiple organizational handoffs required were not consistently evident in the complaint files. At least three (3) independent ·electronic systems were in use by Bayer (IRMS, Argus, Dev@Com) at the same time with manual steps to transfer information between them. o It is not clear why Bayer separated the clinical complaint process and the technical complaint process. During my review, the complaint files showed the disconnect between these independent and non-collaborative silos. Events that could have been caused or contributed to by the Essure® device were often not adequately handled or investigated. If an adverse event was not included in the alleged deficiency, the clinical complaint management team was not involved. If the alleged deficiency did not include a suggestion of a device defect or the device was not returned for failure analysis the technical complaint process did not perform an investigation. 10 9 Section vn A Section VII B iv Gap 1 IO 6 The manufacturers failed to comply with 21CFR 803, Medical Devi~e Repc:ting :Sn that: • My review of the complaint files found little or insufficient evidence the intent of the Medical Device Reporting (MDR) regulations including adverse event and malfunction MDRs was understood by those assigned to make reporting decisions ieading to a significant underreporting ofMDRs. For example: o The manufacturers failed to comply with FDA requirements for Medical Device Reporting in that they did not adequately consider the potential for clinical risk in the events reported to them by complainants. 11 As a result, the manufacturers underreported Medical Device Reports (MDRs) as required by 21CFR803.50. 12 The MDR decision making process used by the manufacturers limited reportable decisions to verifiable adverse events that met their limited definitions of adverse clinical consequences. 13 The use of limited definitions defining reportability resulted in an underreporting of both adverse event and malfunction reports. o The manufacturers consistently limited their definition of the device that could cause injury to only the micro-insert. This approach ignored the entire device system, procedure, and accessories needed to implant the Essure® micro-insert. The patient would not have been exposed to the procedures or accessories had they not been scheduled for an Essure® implant. The Essure® medical device includes the device, the procedures, accessories, the labeling, and the training provided to the users as defined in the Pre-Market Approval of the Essure® device. When this approach was used it resulted in an underreporting of both adverse event and malfunction reports. 14 o Medical Device Reporting (MDR) decisions were often not present, not signed, or. documented rationale for not reporting was often missing, incomplete, or inadequate. 15 The manufacturers failed to provide adequate documented rationale for not submitting MDRs to the FDA as required by 21 CFR803. For example: 'does not meet statutory requirements for MDR reporting'; 'no patient injury or potential injury'; or similar language are conclusions and fail to identify the supporting reason for these conclusions, e.g. why the individual complaint does not meet statutory requirements or why there was no potential for injury.16 11 Section VI C Section VI A 13 Section VII B I Gap I; iii 14 Section VII B iii Gap 2 15 Section VI 16 Section VII B iii Gap 3 and 4 12 7 o The manufacturers' policies reviewed regarding complaint handling procedures 17 do not establish a process of handling FDA notifications of voluntary reports (MedWatch or MedSun reports) submitted directly to FDA by a clinician or patient. FDA has a process to notify the manufacturer of any voluntary MedWatch reports received. 18 These reports must be received and processed in a uniform manner by the Manufacturer as established in their procedure(s). 19 o The manufacturers appeared to rely primarily on "on the job" training and in the materials available it did not appear there was a formal process to review employee work and ensure employees assigned complaint handling and MDR reporting tasks were trained and qualified to perform their assigned tasks.20 • Manufacturers failed to report adverse event complaints to the FDA as MDRs.21 In 24.3% of the sampled complaints, the complaint was MDR reportable. Of these, the Manufacturer only submitted 5.5% of the complaints as MDRs to the FDA. • The Manufacturers' internal policies, procedures, and practices lead to this significant underreporting. The manufacturers almost uniformly failed to report malfunctions as MDRs.22 At times the manufacturers also had a practice to require medical confirmation from the patient's treating physician that the Essure® micro-insert was the direct cause of the injury prior to reporting. At times, the manufacturers had a policy that "caused or contributed" meant that the Essure® insert must have been the direct cause of the injury; not just "a factor" that may have caused or contributed to a serious injury or death. 23 Additional out-of-compliance policies and procedures related to MDR reporting are outlined in the report. 24 17 BAY-JCCP-0062875; BAY-JCCP-0063216; BAY-JCCP-0194281; BAY-JCCP-0196680; BAY-JCCP-0197669; BAY-JCCP0525278; BAY-JCCP-0085106; BAY-JCCP-0062888; BAY-JCCP-0062899; BAY-JCCP-0062909; BAY-JCCP-0062921; BAYJCCP-0062933; BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-0063251; BAY-JCCP-0062986; BAY-JCCP-0063000; BAY-JCCP-0448852; BAY-JCCP-0208840; BAY-JCCP-0208865; BAY-JCCP-1064506; BAY-JCCP0216249; BAY-JCCP-0210778;BAY-JCCP-0205114; BAY-JCCP-0063163; BAY-JCCP-0063168; BAY-JCCP-0063173; BAYJCCP-0063179; BAY-JCCP-0063186; BAY-JCCP-0063193; BAY-JCCP-0063200; BAY-JCCP-0063208; BAY-JCCP-0564291; BAY-JCCP-0140200; BAY-JCCP-0140208; BAY-JCCP-0140216; BAY-JCCP-2272465 (All versions ofSOP-1630, SOP3551.) 18 Medical Device Reporting for Manufacturers, March 1997 19 Section VII Bi Gap l 20 Section IX E (Reglera observations) 21 Section VI 22 Section VI A 23 Section VII B iii Gap 2 24 Section VIl 8 • The manufacturers failed to timely report adverse event complaints to the FDA as MDRs.25 In 20.9% of the sampled complaints, the manufacturers failed to timely report to the FDA and were out of compliance with governing regulations.26 Over half of these untimely MDRs were submitted more than 60 days late. Days late in reporting ranged from a day to greater than two (2) years past when the MDR should have been reported to the FDA. In addition, for 35.1 % of the complaints received, the manufacturer failed to document an investigative decision as to whether the complaint was reportable or not as an MDR. Thus, part of these would presumably have been reportable and were not reported. • Other systemic problems existed. This includes hundreds of complaint files that are missing; a failure for Bayer to report hundreds of legacy complaint files after the acquisition of Conceptus; severe and peivasive backlog of open complaints; and a failure to implement effective changes despite numerous internal audits and 483 letters from the FDA. The manufacturers failed to comply with 21CFR 820.198{b-e), Complaint Files {Complaint Investigation) in that: • Complaint investigations were not uniformly performed using good engineering practices or consistently documented, reviewed and approved.27 • The manufacturers' investigations were often inadequate, incomplete, incorrect or not performed in accordance with the requirements of 21CFR820.198. Of the complaints sampled, 88.5% exhibited some type of non-compliance with the regulations governing complaint investigation, either in the decision to investigate, the execution of that investigation, or the documentation of the investigation. Of those sampled, 25 .3 % of the complaints had inadequate "investigation decisions" due either to lack of documentation or lack of rationale justifying why "no investigation [was] required." In addition, 79. 7% of those complaints with an investigation issue had inadequate "investigation execution" which means that the actions were insufficient and conclusions out of compliance with regulations. Of complaints with an investigation issue, 82.2% had deficient documentation. • For example: o Manufacturers' procedures were inadequate to guide investigations in the areas of: returned versus not returned devices, depth and breadth of investigation, investigation conclusions and resulting actions, or risk documentation such as health hazard evaluations, component risk, failure history, and complaint history. The manufacturers' internal procedures did not contain requirements defined in 21 25 Section VI C This number includes the initial MDRs not reported at all and MDRs not reported in a timely fashion. 27 Section VII B iv 26 9 CFR 820.198(d) (l-3) to determine whether the device failed tc meet specification, was being used for treatment or diagnoses, and the relationship, if any, of the device to the reported incident or adverse event. o Investigations were sometimes closed with no product returned and without due diligence to retrieve the product or to perform an analysis on equivalent product. o During our review of the complaint files, the justification or rationale for no investigation was often inadequate, incorrect, or not documented. Common examples of the inadequate justifications observed during review include the following: o • TJ-03310 (technical justification) was used in some complaints to support the position that a 'clinical observation' did not need a device evaluation. In some complaints that referenced this document, no investigation or device failure analysis was performed. The technical justification is unsupported and contrary to FDA requirements. Complaint records are required to state why, on the merits of individual cases, no investigation is required. • A memorandum was used in some complaints to document that complaints alleging a bent tip would not be investigated. The manufacturers did not consider that a bent tip could be caused by a manufacturer or a design defect. • Tubal Spasm reports were not investigated based on the rationale they were use errors or patient anatomy even though there was evidence of bent tips. During our review of the complaint files, investigation conclusions of patient anatomy, procedure related, physician error, technique, misuse, or similar nonmanufacturer related causes were often not adequately supported with documented evidence. The following examples were observed during review of the complaint files: • • • e, Investigations did not routinely consider additional action such as relabeling, contraindications, training, CAPA, or field action for misplacement, misinterpretation of HSG, time of implant after delivery, patient size and anatomy, or other causes of complaints. If the device met specifications or no device was returned no action was considered to reduce complaints or resolve patient concerns. Some investigation results blamed patients in a disparaging manner by suggesting the cause was due to the patient's mental health, size, or anatomy. As a result of this systemic failure to adequately investigate complaints received, there was a large subset of complaints in which we were unable to determine if they were reportable as MDRs under 21 CFR 803.50 or not. Of the complaints sampled, 57.1 % had insufficient 10 investigations or documentation from which reportability could be determined. It is our opinion based upon our experience and review that the failure to properly investigate complaints received and obtain the relevant information lead to underreporting of l\,IDRs to the FDA. The manufacturers failed to comply with 21CFR 820.180, Record Management in that: • Complaint records were often incomplete, incorrect, or inadequate. For example, during review we observed the following: o Many reviewed complaint files included unsigned or undated documents, forms, and e-mails. o Many reviewed complaints files contained documents in languages other than English that were not translated into English. o Many reviewed complaint files were closed without ensuring follow-up on open actions such as requests for returned product or complainant requests for HSG reviews. o Many reviewed complaints were missing documents or content required by the manufacturers' procedures or by FDA regulation. The manufacturers failed to take action when informed of non-compliant complaints or noncompliant process elements in that: IV. • Form FDA 483 observations of objectionable conditions were identified during FDA inspections related to l\,IDR reporting decisions on perforations. The manufacturer committed to actions but did not fully execute on these actions. The manufacturers failed to adequately take systemic corrective actions to prevent a recurrence of the noted objectionable observations. • Reglera was hired by Conceptus to perform a mock FDA inspection and documented noncompliances to regulatory requirements in complaint handling and l\,IDR reporting. The manufacturers failed to take adequate systemic corrective actions to prevent a recurrence of the noted observations. METHODOLODY OF REVIEW AND STATISTICAL RATIONALE It was represented to me by Counsel for Plaintiffs that manufacturers provided a series of spreadsheets that contained lists of complaints, complaint file numbers, date received, and other information to the Plaintiffs. From those spreadsheets Plaintiffs then requested all complaints that appeared possibly to be associated with a serious injury or death. Some of the complaints requested involved malfunctions that were known to be associated with injuries, such as 11 deployment difficulties, bent tips, and detachment issues. Plaintiffs did not request administrative complaints, including packaging complaints or patency complaints. In addition, Plaintiffs removed any complaint that appeared to be for a healthy uterine pregnancy. Ultimately, approximately 45,449 complaints were requested from the manufacturers. I, along with the other expert consultants, developed and implemented an Essure® Complaint/MDR Review protocol. The purpose of this protocol was to establish the method for review and analysis of complaint records and U.S. Medical Device Reports (MDRs) provided by the manufacturer as part of Essure® Case No. JCCP 4887 in order to determine how and to what extent Conceptus/Bayer failed to report complaints to the FDA that were required to be reported under governing regulations. The record reviews were performed collaboratively by consultants that are experts in U.S. 21CFR§803 and §820 and complaint analysts overseen by the expert consultants. The scope of review was determined to include years 2002 -2015 inclusively. A total of 34,770 unique complaint records were identified as having an aware date in these years from the complaint spreadsheets provided by the manufacturers. A random sample of 5,182 records were selected for review according to the sampling plan discussed in Section V. Administrative Returns and complaints related to legal cases were excluded from the scope and, when found, these were replaced from a pool of additional randomly sampled complaints. For each complaint reviewed, a yes or no answer was documented to answer the question: Was this complaint out of compliance with FDA regulations 21CFR§803 or §820.198 et seq.? Each complaint either successfully met the regulations or failed to meet the regulations. The expert consultants developed a sampling plan in order to determine how often Bayer/ Conceptus was noncompliant with the FDA regulatory requirements defined in 21 CFR §803 and 21 CFR §820.198. The purpose of the sampling plan is to review a statistically significant subset of the approximately 45,000 complaints received rather than review 100% of available complaints in order to obtain an estimate of regulatory compliance. The samples reviewed were used to determine, with a high degree of assurance, the proportion of the complaint population that is noncompliant. A. Sample Size Selection Because each complaint was reviewed to assess whether it successfully met the regulations or failed to meet the regulations the use of a binomial distribution sampling plan was applicable. "In general, a binomial distribution applies when an experiment is repeated a fixed number of times, each trial of the experiment has two (2) possible outcomes (success and failure), the probability of success is the same of each trial and the trials are statistically independent".28 The sample size selected was based on a 95% confidence level that the true value in the population is within +/-5% of the value determined in the sample size. The selected random sample size was 28 Sample Size for Estimating A Proportion, Statistical Outsourcing Services, Steven Walfish. 12 392 for each year, with 100% sampling in years with less than the required sample size cf 392 complaints per year. The use of binomial sampling plans with a 95% confidence level are consistent with the sampling plans used by the FDA during inspections of manufacturing facilities. 29 The sample size was selected commensurate with the risk of an error in the estimate, or confidence level and the confidence level describes the risk of error that we accept in the point estimate. For example, with a sample of 392 samples per year and an identified 50% nonconformance rate, we have a 95% confidence the true rate of nonconformance is between 45% and 55%. For a binomial distribution this is true for any non-sampled population size. Based upon the selected sampling plan, the table below reflects the number of samples of complaint records randomly selected for review to form the opinions herein. Table 1 Quantity of Complaints Reviewed Year 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Grand Total Count of AR · Number 86 392 392 392 392 392 392 392 392 392 392 392 392 392 5182 B. Statistical Analysis The data collected was verified prior to data analysis. Data analysis included a two (2) step approach. Step 1 includes the activities of data conditioning and tabulation, e.g. the actions of extracting data where multiple selections are allowed and tabulating the quantities of each. Step 2 29 QSIT Manual, Quality System Inspection Technique, Guide to Inspections of Quality Systems, August 1999, Section Sampling Plans: Instructions & Tables 30 Sample Size for Estimating A Proportion, Statistical Outsourcing Services, Steven Walfish, 1 Oct 2019. 13 includes the analysis of the conditioned and tabulated data into categorical responses and statistically based responses. The confidence intervals can be narrowed from +/-5% by calculating the actual confidence interval for the accumulated results per year. Based on the distribution of the complaints supplied, the total sample size was 5,182 complaints, which gives a half-width of ±1.4% at 95% confidence for the whole population. 30 The sample size determination assumed a proportion of 50% as this provides the widest interval based on the binomial formula. The actual confidence interval for a sample size of 392 will be smaller than ±5% as the proportion moves away from 50%. V. COMPLAINT AND MDR REVIEW PROTOCOL AND EXECUTION31 The randomly selected sample set of complaints were reviewed according to the established protocol. Complaint reviewers were trained, and their training effectiveness verified prior to unsupervised complaint assessment and recording. Complaints associated with legal cases or administrative issues, such as inventory transactions or shipment errors, were removed from the sample set and replaced with a different randomly selected sample from the same year. Each reviewer reviewed the complaint records provided by Bayer that corresponded to complaint numbers in the sample set selected. Each complaint was reviewed against regulatory requirements based on its own merits and the information made available in the records supplied by the manufacturers. The complaint review and evaluation process were based upon our industry experience and the following references and guidance: • • • • • 21CFR§820.198, Complaint Files 21CFR§803, Medical Device Reporting https://www .fda.gov/Safety/MedWatch/HowToReport/DownloadForms /ucm149236.htm FDA Guidance Document, Medical Device Reporting for Manufacturers, Food and Drug Administration, March 1997 FDA Guidance Document, Medical Device reporting for Manufacturers, Food and Drug Administration, November 8, 2016 For each complaint reviewed, a yes or no answer was documented to answer the question: Was this complaint out of compliance with FDA regulation 21CFR§820.198 et. seq. or 21CFR§803 et. seq.? Each complaint either successfully met the regulations or failed to meet the regulations. A summary of reporting criteria is attached hereto. 32 30 Sample Size for Estimating A Proportion, Statistical Outsourcing Services, Steven Walfish, I Oct 2019. Essure® Complaint/MOR Review, Revision B 32 Review Criteria for Sampling ofS,182 Complaints. 31 14 Complaint file charactenstics were selected from predetermined drop-down options and recorded for each complaint in five (5) primary process categories: • Identification and Handling • MDR Reportability and Submission • Investigation Decision, Execution and Documentation • Actions Taken and Complaint Record Content • MDR Timeliness The MDR determination decision was divided into the categories of: • Yes - an MDR was sent by Conceptus/Bayer • No - an MDR was not sent by Conceptus/Bayer The MDR = No category was further stratified during analysis into: • No - an MDR was not sent by Conceptus/Bayer • Yes - Reviewer - an MDR should have been sent by Conceptus/Bayer but was not • Unknown -MDR reportability could not be assessed on the available information due to limited information documented by Conceptus/Bayer Issues identified during the review were classified according to the table below and documented by each reviewer: Table 2 Com laint and MDR Review Process Group Process Cate o Potential Issues Regulation - Major: Reported event/issue not identified and treated as complaint 1. Identification & Handling - Major: Information not captured in complaint (e.g. not all reported problems are included within the complaint) 820.198(a) • Minor: Limited details/understanding of event. Lack of follow-up to gain additional information and supporting documentation with no objective evidence for diligence. - Minor: Faulty complaint assessment (i.e. event incorrectly identified as a du licate - Major: Incorrect decision (FDA) • MaJor: Missmg non-reportable rationale Reportahtl1ty Decision • ·MaJor: Rat10nale not supported and/or m1ssmg appropnate reference to a prior, snmlar complamt investigation · Ma or: M1ss1 dec1s1on information - Major. Report not sent . 803.50 803. 56 · • Major: New mformatmn did not trigger need to reassessment and supplement (or m1tial) filtng • Minor: Wron MOR Report Content (MedWatth Form 3500A) ort submitted - MaJor: Inadequate or mcorrect MedWatch content - Minor Incorrect supplement (e.g. supplement to wrong device) · 15 ,1, 803.50 ·, 803.52 Group Pro~ess Cate2ory Investigation Decision Potential Issues Regulation - Major: Decision to perfonn/not perform an investigation is not documented 820.198(b) - Major: Rationale to su1>1>ort "no investigation required" .. . - Major: Inadequate investigation Actions Root cause identification Conclusions 3. Investigation Execution - Major: Inadequate MOR-related complaint investigation didn't determine: Whether the device failed to meet specifications Whether the device was being used for treatment or diagnosis The relationship, if any, of the device to the renorted incident or adverse event . . 820.l98(c) 820.I98(d) 803.50 . Investigation Documentation - Minor. Inadequate documentation of complaint investigation 820.198(d) 820.198(e) 803.50 Actioris Taken - MaJor: No actions taken, when should have - MaJor; No cons1derat10n for escalation (CAPA, recall) · 820.198(e) ' - Minor: InadeQuate documentation 4. ~~' Record Content - Major: Mrnsmg content (FDA requmid) ' 5. Timeliness MOR Reoortin2 ' - Major: Required timeframe exceeded . :· 820.198(e) 803.50 803.52 803.10 At the completion of the 5,182 complaint reviews, data was merged, verified, and analyzed to compile this report. Perforations: Methodology on Reviewing Essure® Complaints Involving Perforations During the course of our review of the 5,182 samples a perforation was considered a reportable event unless it was completely asymptomatic and did not require a secondary procedure. This protocol is a conservative approach. It is my opinion that the vast majority of perforations caused by the Essure® accessories would also be reportable as a device malfunction or adverse event. This includes perforations caused by the Essure® micro-insert, delivery system, and accessories (such as the scope required in the procedure). Manufacturers of medical devices are required to submit reports to FDA when they receive or otherwise become aware of information from any source which reasonably suggests that one of its marketed devices [21 CFR 803.50]: • • May have caused or contributed to a death or serious injury or Malfunctioned and the malfunction of the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur 16 'Caused or contributed' is defined by FDA [21 CFR803 .3] as meaning that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of (I) Failure, (2) Malfunction, (3) Improper or inadequate design, (4) Manufacture, (5) Labeling, or (6) User error. When a manufacturer receives a complaint that alleges a product/problem combination involving their device, they are required by 21CFR820.198 to evaluate the event to determine if an investigation is necessary, and to determine whether the event is reportable to the FDA under 21CFR803. Each complaint must be evaluated on its own merits. The results of these evaluations must be documented to provide evidence the evaluation occurred and to document the reason for resulting decisions. For example, in some complaints the manufacturer determined a perforation was caused by a hysteroscope manufactured by a different company (reference complaint numbers from Form FDA-483 for FDA Inspection dates 12/8/2010- 1/6/2011).33 Because the hysteroscope is required to be used in the Essure® procedure (reference IFU and user training material) and the patient would not be subjected to the hysteroscope if not for the marketing of the Essure® device, the Essure® device is considered contributory even if not causative. The FDA has provided for the inclusion of concomitant products in the MDR form. Further, the FDA expects any injury or potential injury that may have been caused by a different manufacturer's device to be reported, either to the other manufacture or to the FDA, so that occurrences could be monitored for the protection of public health. I saw no evidence Conceptus notified hysteroscope manufacturers or any other concomitant product manufacturer of complaints where their products may have been causative. 33 BAY-JCCP-0911996 - FDA 483 complaint numbers referenced are the following: AR-18337 and AR-18681. 17 VI. ANALYSIS RESULTS: THE MANUFACTURER FAILED TO ADEQUATELY AND T™ELY REPORT MDRS TO THE FDA OR ADEQUATELY INVESTIGATE, DOCUMENT, AND MAINTAIN COMPLAINTS AS REQUIRED BY FDA TO THE FDA A. The Manufacturers Failed to Report adverse event and malfunctions MDRs to the FDA and thus Prevented Information from flowing to the FDA. Quality System Regulation 21 CFR 803 establishes the requirements for medical device reporting, e.g. for reporting complaints as MDRs to the FDA. This regulation also defines the requirements for manufacturers to establish and maintain MDR files and to submit follow-up reports. According to 21CFR803.l, these reports help the FDA "to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use."34 The following subsections of 21CFR803 were used during our review of the complaint files: • 21 CFR 803.10 includes the requirement for manufacturers to submit l\.iIDR reports to FDA no later than 30 calendar days after the day that the manufacturer becomes aware of a reportable death, serious injury, or malfunction. • 21CFR 803.50 includes the requirement for manufacturers to report a complaint to the FDA if the complaint reasonably suggests that a distributed device: o May have caused or contributed to a death or serious injury, or o 34 2i Has malfunctioned and this device or a similar distributed device would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. • 21 CFR 803.52 includes the requirements for the information that must be submitted to the FDA in a medical device report. • 21 CFR 803 .56 includes the requirements for submitting supplemental l\.iIDR reports to the FDA. • 21CFR820.198(d) requires that "Any complaint that represents an event which must be reported to FDA under part 803 ofthis chapter shall be promptly reviewed, evaluated, and investigated .. .In addition to the information required by §820.198(e), records of investigation under this paragraph shall include a determination of: (1) Whether the device failed to meet specifications; cm. 803. ~ (a) 18 (2) Whether the device was being used for treatment or diagnosis; and (3) The relationship, if any, of the device to the reported incident or adverse event." The vioiations of these specific subsections of 21 CFR 803 found during the sampling of complaint files are illustrated in below in Figure 2. 21 CPR803 Nancompliances in Sam;,le Set by Specific Reguiation 2000 ~ 1800 :§ 1000 §- 140G j~ i200 ;:: 1000 0 8C() .~~ 60C ,a 4GC 20(1 0 0 2009. 201(1 2002 2003 2004 2005 2006 2007 () () () () 1 1 5l03.52 4 66 51', 56 118 80J.50 292 241 7'83W 152 Jg 680 505 397 312 · 803.Hi 19 143 119 2(4 243 223 i69 264 i36 2()(} 802.56 2008 4 } 99 :' 7li 201 I 2012 2 20D 2 ~~ _:, 59 46 n6 337 195 371 244 :23 854 l 162 JJ.?, 280 364 37l 2014 1 2015 ..,, Figure 2 Noncompliance to 21 CFR803 in Sample Set The data was further analyzed for the complaints with at least one (1) violation of 21 CFR803 and then extrapolated to the entire population. This analysis is represented in Figures 3-4. 500 er 3-~3 c:'. 40() ·ro ~30G 8 20G .;:, IOC 0 0 i4f [(; 2:J02 200::; 2;)G4 2:005 2006 2WY7 200:i 2009 Year Figure 3 19 2010 20l i 2G!2 2013 20!er 95% Confidence Interval Uppet 95% Confidence Interval Year Quantity of Complaints with Aware Dates in Total Popnlation Lower95% Confidence Interval Extrapolated 86 5% NIA NIA 2002 86 4 392 17% 14% 13.30% 10.50% 2003 448 2004 672 392 17% 35% 13.30% 30.50% 392 10% 7.20% 2005 2006 2007 813 1,748 1,167 392 23% 18.90% 2008 392 16% 14% 12.80% 10.30% 2009 1,301 2,398 2010 3,645 8% 5.20% 20.92% 17.59% 20.92% 40.16% 13.35% 27.45% 20.36% 17.31% 10.75% 2011 4,351 60 71 108 533 84 246 307 375 226 392 392 392 392 35 BAY-JCCP-6804054 Complaint AR03572, date Conceptus aware of incident 31 Sep 2003. 23 ExtrapoJated Quantity of oomplainn that should havebten Reported Upper9S% Confidence Interval Extrapolated 4 4 75 94 118 170 702 156 357 488 631 468 93 137 615 116 299 392 493 333 Complaints that should have been reported as Initial MDRsin ~%of Quantity of Number of complaints reviewed in Sample Set reviewed tut should h•ve been reported Lower 95¾ Collfidence Interval Upper 95¾ CoJlfidence Interval Year Total (Sample Set) Sample Set QW1Atityof Complaints with Aware Dates in Lower95% Extrapolatff. Quantity of Confidence Interval Extrapolated complaints . that~hollld have been Population Reported . Upper95% Confidence Interval : Extrapolated 43 392 11% 8.10% 14.49% 2012 4,735 384 519 686 46 392 392 12% 8.70% 15.34% 2013 4,338 377 509 32% 27.80% 37.28% 2014 3,228 1,046 392 39% 34.40% 5,840 2,294 2588 5182 19% 17.70% 44.31% 19.89% 2015 897 2009 665 1203 Total 34,770 6,154 6,535 6,916 127 154 974 21 CFR §303 Vidaticns - Ranges Extrapolated to the •Xi".1c.:"" ·;;r.r:,.;,,;..;C ·1-i ~,;,_-'~--LU.,..._ . :'l ,_..._ ' -"-" ..._ .w. 3000 If/ 25~)0 2')00 !// ,,, . 1500 f(} ~.1~· 1000 500 ~>l ,•-, ..r ; ' ..#:·~·:,~ ..,,,,,/Y 0 2002 '2:l03 2004 2005 2006 :007 ~008 20()9 20 I() 2011 20 i 1 2013 2[!14 2() 15 ·--Min Extrapn1atod ·--Extrapolated Quantity of c:om!)Jai111s that s!loelJ ha\'C been Reported (.Midp,'.l(;:it) --Max E:arap:illltod Figure 6 Ranges Extrapolated to the Whole Population - 21 CFR §803 Violations 24 In 2015 the FDA held an Advisory Committee Meeting on the Essure® device. The FDA produced a PowerPoint presentation for use in this meeting. Slide 24 summarized the various sources and volume ofEssure® MDRs the FDA had received 2004-May 31, 2015.36 Slide 24 of this presentation is depicted below as Figure 7. The information available to the FDA would have been much greater if the manufacturer had reported complaints as required to by FDA regulations. 37 MDRs Received (Through May 31, 2015) N=S,093 ,:•It'... :• IO l - ··· .. ,-'~ : _,.- f: ., "'I-' , ,J. / 1 ·. ... J '; - Figure 7 FDA Advisory Committee PowerPoint Slide 24 To reflect the results of our analysis, we amended this chart to add the estimated (extrapolated) reports that should have been reported by the manufacturers but were not (identified in our analysis as Yes-Reviewer). This amended chart is shown below in Figure 8: 36 FDAPUB0000780 25 FCA ::i:-esentvt:0:1 S:i ::..e 24 Rev•sed F.:-;~ r\·DRs 2J04 \.~a\• 31 2C15 ~N=:0.200; 2015 includes only s months • Figure 8 Extrapolated Reportable MDRs In the original FDA presentation slide, 1,289 MDRs were submitted to FDA between 2004 and May 31, 2015, from the manufacturer. If the manufacturer would have submitted the MDRs as identified in the review analysis between 2004 and May 31, 2015, (e.g. including the YesReviewer extrapolated numbers to the FDA Slide 24 data), FDA would have received 1,289 MDRs mid-2008 (1,070 at end of2007). 38 In the original FDA presentation slide, a total of 5,093 MDRs were submitted to FDA between 2004 and May 31, 2015, from all somces. If the manufacturer would have submitted the MDRs as identified in the review analysis ( e.g. including the Yes-Reviewer extrapolated numbers to the FDA Slide 24 data), the FDA would have received no fewer than 5,093 MDRs early in 2014. If the manufacturer would have submitted the MDRs as identified in the review analysis, a rising trend in 2004-2006 should have been identified and an investigation initiated. Likewise, the sharp reduction occmring in 2007 should also have been identified and investigated. When normalized for number of devices sold, the data continues to exhibit signals that should have alerted the manufacturers and the FDA to investigate the following signals: (a) A raw data signal in 2006 (rising trend and spike); (b) a raw data signal in 2011-2013 (rising trend) (c) a raw data signal in 2007 (sharp reduction); (d) A raw data signal in 2007-2009 (rising trend). 38 See Table 10. 26 Brea:{-out ::,f lv'ORs per 1000 devices sold Fer 'JiDF:s 2004 - 2013 { Fur/\, r",ing ,,.µ,01 s11ouH have resulted I , lo Nthonrer1 mo11110Tinp, at minimum , \ i Ri,;rrg trendr~~;re; _ )'.,\ : l/llii.:stjg.1tio11 '7 ✓~-- '\ //' 1/ Figure 9 Break-out of MDRs per 1000 Devices Sold A closer look at the early years reveals the dramatic spike in 2006 and subsequent decline in 2007: _;_u_ r ..._..7,, .'·· 20C ,' I, Figure 10 From2004 to 2012, the manufacturers submitted only 334 complaints as MDRs to the FDA under 21 CFR 803. In addition to the non-compliances related to the failure to report, the reviewed complaints did not comply with the following MDR related requirements. Specifically, • 21CFR820.198(d): 1,819 were missing a documented MOR reportability decision. (35.1%). 27 21CFR820.198(d): 2,963 were missing rationale to support not submitting a Medical Device Report or the documented rationale was not supported by evidence. (57.2%) • 21CFR803.56: 20 included new information that did not trigger a new MDR assessment. (0.4%) • 21CFR803.52: Of the 284 complaints where MDRs were submitted by the manufacturers to the FDA in the samples reviewed, 175 (61.6%) had inadequate or incorrect content. Table 5 provides examples of MDRs with inadequate or incorrect content. 1 rv·IO1atiODS 0 f 21 CFR 803.52 Ta ble SExampeso Date FDA ARNumber Comment Received MDR Did not reference MW5032935 as required by FDA 2014-009433 12-Feb-2014 letter, Miscoded product code as KNH instead of HHS MDR did not mention that the patient had a supracervical hysterectomy, just laparoscopic device removal. Product 2014-030562 20-Mar-2014 code KNH used, patient demographic information missing. Date received by the FDA 5/29/2014. Required 2014-065790 29-May-2014 intervention but not selected. Section D has some blanks that could have been answered. B2 blank even though adverse event was selected. Date 2015-025880 12-Mar-2015 of event left blank. No patient identifier or age. Malfunction selected. Hl0 was left blank. Contradictions within the text. It states that no surgical 2015-034244 25-Mar-2015 intervention was reported but also that patient had a hysterectomy. 9 AR050598 AR-11220- swvs 19-0ct-2005 2/19/2010 AR-15676CJ02 23-Jul-2010 AR-17368ZQB7 3-Nov-2010 incorrect MDR number assigned by E. Sinclair Age ( age was stated in patient notes and could have been recorded), DOB, Weight of patient missing, HI - Type of reportable event listed as "Other: Patient Reaction" instead of serious injury, Device manufacture Date not listed. Summary states that the first micro-insert was removed due to perforation but no mention of the pregnancy termination or lap tubal procedure. The MDR is an Adverse Event and was classified in the MedWatch Report as a Product Problem. Content errors with B2 Outcome: Hospitalization, B3 Date of Event is not date of first surgery, B4 Date of Report I 0/18/2010 is not become aware date nor MedWatch submission date, BS report was received from patient (not initially dr) who reported severe symptoms for multiple years with hysterectomy, G4 Aware Date: is 9/13 not 10/4. 28 B. The Manufacturer Failed to Submit Timely MDRs and Supplemental MDRs to the FDA and Delayed Information Available to the FDA. The manufacturers failed to comply with the FDA requirements for timely submission of MDRs and failed to submit supplemental MDRs as required by 21CFR803. 109 of the 284 MDRs the manufacturers submitted in the sampled population (38.4%) were not submitted to the FDA within the required timeframe of 30 calendar days per 21 CFR§803 .10(c)(1 ). The number of days late ranged from one (1) to 1,763 days. The average days late for the 109 MDRs is 556 days with a median value of 162 days. Table 6 below provides some examples of these late MDR reports. t MDR SU b IDISSIOll . . E xampIes T able 6 L ae Due Date Complaint Number Aware Date (Aware Date+ 30 Calendar Days) DateFDA Received Report How Many Days Late? MDR# Injuries Associated with this MDR . asthma symptoms, sensitivity to jewelry, positive nickel test, device removal and Hysterectomy severe chronic pelvic pain, rmgrames, constant vaginal bleeding, Hysterectomy Constant abdominal and pelvic pain. nickel allergy, migraines, weight gain removal, partial hysterectomy, salpingectomy, psychological/psyc hiatric, dyspareunia AR133115Z8V 5-Mar2010 4-Apr-2010 .l 7-Sep-2010 166 2951250-201000052 2014008427 13-Jan2014 12-Feb-2014 19-Dec-2017 1406 2951250-201710898 2015351467 15-Jun2015 15-Jul-2015 13-Jul-2018 1094 2951250-201803042 13-Jul2007 · 12-Aug-2007 25-Sep-2009 775 2951250-200900053 Perforation 19-Dec2008 18-Jan-2009 4-Aug-2009 198 2951250-200900033 Perforation AR02047XJ7J AR06184MU18 29 Each MDR report not submitted to the FDA by the manufacturers is also a late report. The following graph illustrates the combined occurrences of late MDR reports (both not reported and reported late determinations). 1. f•; •.-:'.. 12 weeks or Unknown Complications Durine: Essure® Placement VasoVagel response roouiring intervention Fluid Deficit 35 Should have been Reported by the Manufacturers Grand Total 4 4 4 4 Forei2n Matter 4 4 Miscellaneous 2 1 2 1 1 2 2 Unspecified details 1 1 During procedure or during intervention 1 1 1 1 Reported by the Manufacturers Injury or Potential Injury Expired Device Implanted (blank) penile pain Bilateral Salpingectomy to remove device after genetic testing Death Sterility Not Assured Sharp Edee Clinician Injury 1 1 1 1 284 Grand Total 36 1 974 1258 !. Additional Injury 9r Potential Injury Analysis At the request of the regulatory experts, we further reviewed the complaints marked as ''yes-reviewers" or as complaints that should have been reported but were not reported as MDRs to the FDA between 2002 and 2008 40 . The complaint files in this group were reviewed to identify relevant reported injuries. Specifically, the relevant injuries included perforations, migrations, surgical removals, deaths, and the occurrence of additional medical intervention. The reportability criteria for defining which perforations, migrations, and surgical removals, were reportable as MDRs was established by the regulatory expert for purposes of this section. This reporting criteria was more conservative than what was used in our record review. We also included in the review the MDRs actually submitted by the manufacturer to the FDA between 2002 and 2008 and performed the same assessment as described above. The reportability criteria for Perforations and Removals were further refined to be even more conservative for this additional review. The criteria used is listed below: 1. Perforation (see detailed notes below); 2. Removal of the Device (either planned, actual, or recommended removals ofthe device that occurred at any point after placement - see detailed notes below); 3. Migration or Expulsion out of the fallopian tube (either into the uterus, abdominal cavity, peritoneal cavity, etc.); 4. Additional Medical Intervention Required (defined as an additional surgery, hospitalization/emergency room visit, prescription medication, or allergy testing); 5. Whether the patient later received a laparoscopic tubal ligation or Filshie clip procedure; 6. If fetal death (spontaneous abortion, voluntary abortion, or ectopic/nonviable pregnancy) or patient death occurred; 7. And whether the failure mode assigned to the complaint by the manufacturer failed to represent the severity of injuries within the complaint. Perforations and removals were reviewed using the following criteria. Perforations were considered reportable events if the following occurred: • • Perforations with symptoms (pain, bleeding, fluid deficit etc.) that lead to medical intervention such as surgery, extended hospital stay or prescription drugs, are reportable as MDRs. Perforations that are caused by the Essure® System malfunctions (including introducer, catheter, micro-insert leading to rollback, deployment difficulty, etc.) resulting in medical intervention such as surgery, extended hospital stay, or prescription drugs are reportable as MDRs. No symptoms required. 40 Analysis was revised to include years 2007 and 2008 to fully answer the Regulatory Experts questions and be consistent with corrected Injury Analysis Tables 9, 11-14. Additional footnotes throughout this section are included for additional clarification to the analysis herein. While the numbers have been corrected from the previous version of this report, the methodology used remains the same for estimating injuries in the population. 37 Perforations that met the criteria below were defined as not reportable: • • • • Perforations (device dislocations) that are asymptomatic and do not require further intervention. Perforations (device dislocations) that occur at the time of Essure® placement that lead to a BTL/ Fillshie clip procedure. Perforations (device dislocations) that occur with non-Conceptus/Bayer devices including the hysteroscope or graspers. Device dislocations/ migrations into the abdominal cavity with no symptoms Surgical removals that met the criteria below were defined as reportable: • • • Removals of the Essure® micro-insert ( or pieces thereof) due to patient symptoms (pain, bleeding, allergy, infection). Hysterectomy or salpingectomy or laparoscopy performed to remove embedded Essure® from uterine cavity/cervix Removal due to device breakage or system malfunction (bent tip, could not disengage, thumbwheel doesn't work), whether upon initial deployment/implant or occurring after the day of implant, whether or not patient symptoms were documented. Removals that met the criteria below were defined as not reportable: • • • • Removals that are at the patients request only. Removals where symptoms such as pain or bleeding is not caused by Essure® Removals with statements from HCP that the adverse event is not caused by Essure® and no improvement in symptoms is seen after removal Removals41 due to unsuccessful surgery (except for device breakage) where the device cannot be placed-performed at the same time as attempted placement. The results of this analysis are detailed below and includes the information that the FDA should have had, but did not, by each year. Based on the statistical rationale previously discussed in Section IV, we can estimate the occurrence of these injuries in the larger population for each year. Extrapolating the injuries by category for each year gives the following estimate for the whole population: 41 Changed to state removals consistent to prior bullets. 38 Table 9 Year 2002 2003 2004 2005 2006 2007 2008 Totals Additional Incorrect or Inaccurate Removal Perforation Migration Medical Failure Mode Assigned (Recommended (any) (any) Follow-up by Manufacturer and actual) Required (Reference Table 25) 0 0 100% 0 1 14 28 83% 9 41 14 13 15 32 75% 27 18 17 70% 46 35 37 24 88% 74 17 25 97% 13 33 23 32 29 68 76% 130 153 107 295 NIA We can, therefore; conclude the manufacturers should have reported the following additional MDRs to the FDA between 2002 and 2008 inclusive: • 227 migrations and/or expulsions outside the fallopian tube should have been reported to the FDA by early 2008 (217 by end of2007) based upon the sample. • 300 perforations (as defined above) should have been reported to the FDA by 2007. • 4 3 7 removals (either recommended or planned) would likely have been reported by 2008. • 852 patients needed additional medical intervention ( either an additional surgical procedure, hospitalization, emergency room visit, prescription medicine, or allergy testing) post-implant by 2008 (626 in 2007). • If the manufacturer would have submitted the MDRs as identified in this review analysis, FDA would have received 1,289 MDRs mid-2008 (1070 by the end of 2007). • Finally, at least two (2) ectopic pregnancies (fetal death) by were identified by 2006 that had not been reported. Table 10 Cumulative Estimate of MDRs Year Quantity of Complaints that should have been reported as Initial MDRs in Sample Set Extrapolated Quantity of complaints . that should have been Reported MDRs Actually Sent to FDA by Manufacturer (from FDA Slide 24) 2002 2003 2004 4 66 54 4 75 93 Not Available Not Available I 39 Cumulative MDRs Total MDRs the the FDA should FDA should have have received if the received by year Manufacturer had (Column 3 and 4 Reported Correctly added together) (Each Year added) 4 75 94 4 79 173 Quantity of Complaints that should have been reported as initiai MDRs in Sample Set Extrapolated Quantity of complaints that should have been Reported 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 (through May 31, 2015 only) 66 138 39 90 64 53 30 43 46 127 137 615 116 299 392 493 333 519 509 1,046 5 12 12 38 80 66 60 60 65 555 142 627 128 337 472 559 393 579 574 1,601 315 942 1070 1407 1879 2438 2831 3410 3984 5585 71 556 335 891 6476 Total 974 6,535 1,289 7,824 NIA Year MDRs Total MDRs the Actually Sent . FDA should have to FDA by received by year Manufacturer (Column 3 .and 4 (from FDA added together) Slide24) Cumulative MDRs the FDA should have received if the Manufacturer had Reported Correctly (Each Year added) Table 11 below is utilized to determine the number of injuries estimated to be in the population of complaints based upon the complaints identified in the sample set. The estimate of injuries in the population applies to each injury reviewed (perforations, migrations, etc.) Ta ble 11 Step 1 E stimateof I n.1unes · · m · Popu1ation42 Sample (Yes Year Review+Mfg Sample Size % sample Total Qty in Population Estimate of Injuries in Population 86 392 392 392 392 392 392 4.65% 16.84% 14.03% 18.62% 37.24% 12.24% 27.04% 86 448 672 813 1748 1167 1301 4.0 75.4 94.3 151.4 651.0 142.8 351.8 MDR) 2002 2003 2004 2005 2006 2007 2008 42 4 66 55 73 146 48 106 Table 11 corrected to address typos in column 2 and to remove and simplify rounding throughout. 40 1)~bl~..1~ -~s!!_m~~~ -~fJ>~:rf 2002 - 50 0 200? 2004 2005 2006 2JG7 :;.oos Cumulative Esi~1atio of ? Description: .. ··--·· ...... _. • . . . .. . Qty Returned: Investigator Notes: Example 3 Incident Description field49 tnddent:1~n " • • >- , .· Date of Incident: .•, . . ·· · 1'.i -Mm•-2011 Date CPTS/Oistributor A.ware of Incident:! 16-Jun-20-1"! Country of Incident: Incident Descnption: 48 D,.L_.PHI ··-· :n:po.·i.,,u \,1'o ,n,~idenrns with lh· .:. -,ml'< ~11el"lt ,ifl..,1rec.e111lng me E,:,..::\lr--i r,,,,1ite~ i-1 St<,)l.i•n~1e, 2[,,Xl li)b p.cfa,•l, i:i>;::ar;l, 1,rnc;nad. iiinrl ,:ai'i;f.c i, ,t- lli::b; id! t0rr.1 aid cefr,•111ed 111,:!D~ , by r..-sect:;x1 She /1\31'..1 an r!S:C, d~Jrn.: ,ti ;:;ehruary whct11,hov,od ll\f. l>ir.1 devi'=7-.i~· b., in -1 1,;;ti:,;fr,i:.:"-.,.-Y k:-catiN1 ,,nr! ,)1;!':lud,;;!l b·J! tt,.. right v,<1,:, c.-urlaci up l'lr'!'i p.·•tenl. Ct".!_!fili':fa:J a!,;,., luna, ,,n (5J·,3i11 h 1. 11 was nm 'iL;;, :r; se"' !h,; •i9!1; (J,,,i..:, Th.. pi-;Hent hd~'. AR-31986-3XSW, BAY-JCCP-1124579 BAY-JCCP-11342 80 49 AR-22425-65CN, 53 b) Illegible information - Content is unreadable Example 1 Even! De~cription inde~ipherable 50 I Date ofreceiDtofinformation: 2/19/2014 Local case ID: Initial report 1K] Follow-up report I Follow-{Jp Information requested: D Yes D No GIVE INFORMATION ON 'IHE PATIENT WHO HAS EXPERIENCED THE ADVERSE EVENT : Initials ' Gender.male female :). D !ill ' Age (years} ! I SN:! i PHI i ,_..,J WHICH AoVERsE EVENT(S) HAS TH.E PATIENT EXPERIENCED? 1.see Attached Was the patient hospitalized? ~ I oate: IDate: Date: Yes O No Ix! IDate: Did the patient die? Yes • No[211 Ofi!ICRl91i DeTAILS OF THE ADVERSE EVENT(S) See attached . /~:.;: .. ,-,~:':! ~~- -;l';l'':"· · :,,,:, ,•~.:,d::lt\J:r ·;.. :·. "'tt~.' ! i . ·:-: !,·•,, ,.,. lit' :h.~•-, .1•: : ~ • .~1 •· ~; : -- • !'f' I !,,v,f it. ,;-..·• I" .;t, , ,. ~1_:~·1, ~-:''(. ::1y :;, :;< - - 'J' ~-.; 'll!l .-~~· •. .::·: -,u.~ ~ , •~- r; ; -~, --~' m,, :.1· Related to suspect drug according to Reporter Yes O No For contrast agents, please describe the procedure. {e .g. MRI CT) Example 2 Content indecipherable51 50 51 2014-031479, BAY-JCCP-6905947 2015-016108,BAY-JCCP-4724145 54 .::a._.,, . .o-,~~ .·-' _1~1:_,:~- n'! 1,l;'°':.! ~· ~.- ~•' :.:;:··f;_;, ,-;. •r. ·~!~:~.. .- ,{t'~,:~ li J. · : ·.v · ·-if•. ,..,,ir: y,:·;I" :: . .1 -""~· ··,~,.~ 1- -,~, !"-:: · • ':,,t< '.~ i..i".~: ·1-,.;~i~ •f:r-> . ~";.:' :, '.-••,_. D c) Incomplete information -Content is inadequate Example I Reportability assessment contains "Launch MDR Form" and no associated content52 MDR Form: Mfr. Reports: ." _f i l • • I_; 'r I • !fo.11:taw o~s1!,!;,.,w:-r~-.__ - .- ,·.,·. . :-•_ ,:._;:;,j, . '.· .• Example 2 Reportability assessment decision tree selections not legible53 Event Reporting -·· Mfr R~ru.: --·~t;.,~,,. Decis•on Tree_$__; --USAt>ecislon-Tfff··~:::~...:.. : :~:= ::·;: :'....... USA Report ~ u l t : ~ · - - - - - it.ts an injury or detth i P·"' occucred!' ·-- ·----••-• · ...,__, ! · D: ').fastcr<:outro[:PUB·fostalkdS.:rviccs publish :NTIAL Does th!! ;ii\li'IUablt: tnfMmltion:s.ugges.t U11t tt'l,et>n>cillCt~ n1.altcnctioned? Or)I!!. -a~tl4.bk: .•·, tnformatbn.~uggert tltlit · . T ' •he dwke co.us« or c<>l'ltrtbulvd to t~ death or serous injury? Oos the aYOllablo : 1nformui>ns.ugg1St t1'113t ~ ff' the malfunc.t:ion were U) r-e-o~ur~ 1ha.t-t~ '.j ~"'causeorcor.tribute.to """""l!ld bo\lkeiytoa fiath Of YMoUS ll')}Uf)'f 01"'5 .rhe f'Vent : · ~Ulite NKT'ld'dlat;__ _ ·,; i.Ctton; to pre-~t ;,1~ uor~s,matxe ·risk or sob,untial "'"" t<> public:~lUl!' At least 500 complaint files were requested from the manufacturers that they were unable to locate and produce. The manufacturers admitted they are unable to produce over 500 complaints that were requested for review. 54 52 2014-031479, BAY-JCCP-6905947 53 AR-29775-8605, 54 BAY-JCCP-1123 571 See Declaration of Gabriel Egli, July 12, 20 I 9 (attached).. 55 The manufacturers failed to comply fully with FDA regulations requiring them to maintain and safeguard complaint and MDR files. Manufacturers are required to maintain complaint files and to preserve them in a way that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA designated to perform inspections. See 21 CFR 820.198; 820.180. This maintenance responsibility exists for a period of time equivalent to the design and expected life of the device, but in no case less than two (2) years from the date of release for commercial distribution by the manufacturer. Id. Essure® is a permanent sterilization device, designed to last a lifetime. The manufacturers' have a regulatory obligation to maintain and safeguard related complaint and MDR files until every device recipient dies or has the device removed. VII. GAP ANALYSIS: A REVIEW OF KEY POLICIES & PROCEDURES SHOWED NONCONFORMANCE WITH FDA REGULATIONS AND GUIDANCE. I reviewed Conceptus and Bayer quality system documents from 2002 to 2015 related to complaint handling and Medical Device Reporting (MDR) processes to assess the manufacturers' procedural compliance to FDA 21 CFR §803 and §820.198. Complaint handling and MDR determination processes include the following essential process steps: • • • • • • • Complaint Receipt, Identification and Triage Evaluation (for investigation) MDR Reportability Assessment MDR Report Submission Investigation Action Closure During the period 2002-2015 Conceptus had at least 22 procedural documents and Bayer had at least 20 55 procedural documents describing these processes. I reviewed each version provided by the manufacturers as listed in Table 20. 56 Only documents with an indication of released status (e.g. not drafts) were reviewed. Regardless of year, manufacturer, or version, I found most of the procedures noncompliant, overly complex, and difficult to follow. The organizations involved in the processes and their evolution 2002-2015 as defined by the procedures are described in Section A. The specific procedural gaps to FDA regulatory requirements I identified are listed in Section B below. 55 56 Four (4) were transitioned from Conceptus to Bayer Attached is a schedule of the policies cited to in this section with corresponding Bates numbers for reference. 56 57 Table 20 Procedural Lists and Comparisons Conceptus QMS - Complaint Handling & MDR Processes Release Topic Document Date 8/1/2003 SOP-1630 (rev E) with suooorting Forms Introduced SOP-1630 Various "R" documents R3189 Receipt Complaint Entry R3203 (CRM) R3188 MDR reporting R3186 Investigation R3184 12/2008 (rev AA) US03REG-SOP000609 5/2009 (rev AB) WI-3329 Handling Product Technical Complaints 8/2012 (rev 2) Complaint Handling 6/2013 (rev 4) Global SOP Vigilance 5/2014 (rev 4) MDRadded Global SOP Handling of Individual Case Safety Reports 12/2012 (rev 2) US SOP US SOP Case Triage 11/2012 (rev D) Inquiry US SOP US SOP US SOP Complaint Handling Dev@ComUse PTC File Requirements 8/2013 (rev 1) 8/2013 (rev 1) USSOP MDR Product SOP Product WI 7/2010 (rev AC) WI-3635 WI-3488 Product WI WI-3306 Product WI Work Instruction released WI-3429 Release Date WI-3634 Move to Master Control and WI Complaint capturing US03REG-SOP00063 I (US-SOP-015-BPD) Topic 3/2010 (rev A) Transfer to Complaint (OMS) SOP-1630 US03REG-SOP-ATT-719 SOP-3351 WI-3640 MDR Work Instruction released BDP-SOP-017 US03REG-SOP000623 US03REG-SOP000608 Introduces work instructions Complaint WI-3304 processing WI-3306 Document and Level Company GSOP-115 Directive Policy Global SOP BDP-SOP-082 BHC-RD-WOP-013 US03REG-SOP000593 File Reauirements SOP-1630 Bayer QMS - Complaint Handling & MDR Processes 3/2013 (rev A) WI-3600 WI-3340 WI-3485 58 Product WI Essure® Complaint Handling Triage Complaint Handling in IRM Product WI Complaint Handling in Dev@Com Investigation MDR Processing PTC (!RMS toDev@com) Master Control Product WI Master Control Product WI Product WI 8/2013 (rev 1) 8/2013 (rev 1) 12/2013 (rev 1) 2/2014 (rev 1) 1/2014 (rev 1) 10/2013 (rev 1) 10/2013 (rev 1) 7/2012 (rev 1) 3/2009 (rev A) 3/2014 (rev 1) 7/2010 (rev 1) 6/2012 (rev 1) A. Change in Organizations & Systems Over Time Figure 22 below illustrates the organizations and record systems in use by the manufacturers over time as described in SOP-1630 (all versions), SOP-3351 (all versions), US303REGS - SOP 608 (all versions), and BDP- SOP 082 (all versions). Coottptus (2002) Conceptus (2003) Event · Event T1i:1.3e Customer Sen,ice In Paper/CRM system Customer Service In Paper/CRM system (o:i1_pk:i11.t HNi-:ili!.,g QA/Producl Surveillance Group In Papcr/CRM system l Tv"!)f. • Reg11/a/01J' Group In Paper Crmr,lainr f·b:d!ing :t !nv~:,liga'.i,m Product Surveillance Group In Paper/ CRM system !nve~;ti:;~-.thP. Regulato,y Group In Paper QAIQEIR& D/Proces., EngrGroup In Paper ,- ' Bayer . Conceptus (2010) Event Event Compb.i'll TriP:!t Tri:.:£_;~ Medical Communications Group In [RMS system Pharmocovigilence Group In Argus system Customer Service In Paper/CRM system ho:it1c, k~:m1~a! .::·omr:~m, Technical Complaint Group In Dev@Com system Product Surveillance Group or D esignee (Reg/era) In Paper/CRM system Figure 22 The transition from Conceptus' complaint management process to Bayer's pharmaceutical based complaint management moved the process from a single organization and paper/electronic file to multiple organizations and electronic systems making the process more complex. The multiple organizational handoffs required were not evident in the complaint files. At least three (3) electronic systems were in use by Bayer (IRMS, Argus, Dev@com) at the same time with information transferred manually between them. 59 B. Identified Protedural Gaps The review of key Conceptus and Bayer complaint handling and Medical Device Reporting (MDR) procedures identified numerous compliance gaps to FDA regulatory requirements and determined that the procedures were not adequately established. fdentified gaps are described below. i. Complaint Receipt, Identification and Triage The manufacturers' complaint handling procedures were not implemented to ensure that all events that met the definition of a complaint were identified and processed as required by FDA requirements. FDA defines a complaint (21 CFR Part 820.3) as: "Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution." FDA regulation 21 CFR part 820.198(a) requires that complaint files be maintained, and procedures established for receiving, reviewing, and evaluating complaints by a formally designated unit. These procedures are to ensure that complaints are processed in a uniform and timely manner and oral complaints are documented upon receipt. I identified the following gaps between what is required by 21 CFR 820.198(a) and what was included in the documents reviewed. GAP 1: Not all events that meet the definition of a complaint are considered or treated as a complaint Example: The manufacturers' complaint handling procedures57 do not establish a process of handling FDA notifications of voluntary MedWatch or MedSun reports submitted directly to FDA by a clinician or patient. A defined process is necessary to uniformly handle these reports to: identify if event was previously received, assess for reportability, determine if an investigation is necessary, etc. 58 It should be noted that between January 1, 2002, and August 8, 2003, Conceptus did have a process established for handling FDA notification of voluntary MedWatch or Med Sun 57 BAY-JCCP-0062875; BAY-JCCP-0063216; BAY-JCCP-0194281; BAY-JCCP-0196680; BAY-JCCP-0197669; BAY-JCCP0525278; BAY-JCCP-0085106; BAY-JCCP-0062888; BAY-JCCP-0062899; BAY-JCCP-0062909; BAY-JCCP-0062921; BAYJCCP-0062933; BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-0063251; BAY-JCCP-0062986; BAY-JCCP-0063000; BAY-JCCP-0448852; BAY-JCCP-0208840; BAY-JCCP-0208865; BAY-JCCP-1064506; BAY-JCCP0216249; BAY-JCCP-0210778;BAY-JCCP-0205114; BAY-JCCP-0063163; BAY-JCCP-0063168; BAY-JCCP-0063173; BAYJCCP-0063179; BAY-JCCP-0063186; BAY-JCCP-0063193; BAY-JCCP-0063200; BAY-JCCP-0063208; BAY-JCCP-0564291; BAY-JCCP-0140200; BAY-JCCP-0140208; BAY-JCCP-0140216; BAY-JCCP-2272465 58 Medical Device Reporting for Manufacturers, March 1997 and Medical Device Reporting for Manufacturers, Guidance for Industry and Food and Drug Administration, November 8, 2016 60 reports submitted directly to the FDA by a clinician or patient5 9• I saw no evidence this process was acted upon in the files reviewed. Example: Procedure Product Returns, Complaint Handling and Reporting (SOP-1630)60 defines Procedural Observation as "an event in which customer/user input that does not allege a deficiency of any Conceptus product (e.g. a non-product related incident) such as issues occurring with other instruments during the procedure, damage that can occur during typical use, anesthesia-related complications that occur prior to the insertion of the Essure® device." Following this approach, reported events that were categorized as procedural observations were not handled as a valid complaint and were not investigated. FDA requires investigation for all events meeting the complaint definition. Example: Procedure Product Returns, Complaint Handling and Reporting (SOP-1630)61 defines a Procedural Observation as "a category of reported events that do not meet the statutory definition of "Complaint" found in 21 CFR 820.198 and in this SOP." The procedure goes on to state that, "This category may include post-placement examination results, issues that may occur with other instruments during the procedure, and damage that can occur during typical use. For example, an anesthesia-related complication that occurs during the procedure, prior to insertion of the Essure® device, would be categorized by Conceptus as a "Procedural Observation"." This additional language results in the Manufacturer limiting their identification of a complaint to those involving the Essure® device only (e.g. micro-insert). This approach does not result in the identification of a complaint when the reported event involves the entire Essure® device system, implantation procedure, and accessories needed to implant the Essure® micro-insert, the labeling, and the training provided to the users as defined in the Pre-Market Approval of the Essure® device. An event related to any aspect of the medical device must be considered a complaint. 59 BAY-ESSURE-0009848 - BAY-ESSURE-0009862; BAY-ESSURE-0009862 BAY-JCCP-0062875; BAY-JCCP-0063216; BAY-JCCP-0194281; BAY-JCCP-0196680; BAY-JCCP-0197669; BAY-JCCP0525278; BAY-JCCP-0085106; BAY-JCCP-0062888; BAY-JCCP-0062899; BAY-JCCP-0062909; BAY-JCCP-0062921; BAYJCCP-0062933; BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-0063251; BAY-JCCP-0062986; BAY-JCCP-0063000; BAY-JCCP-0448852; BAY-JCCP-0208840; BAY-JCCP-0208865 61 BAY-JCCP-0062875; BAY-JCCP-0063216; BAY-JCCP-0194281; BAY-JCCP-0196680; BAY-JCCP-0197669; BAY-JCCP0525278; BAY-JCCP-0085106; BAY-JCCP-0062888; BAY-JCCP-0062899; BAY-JCCP-0062909; BAY-JCCP-0062921; BAYJCCP-0062933; BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-0063251; BAY-JCCP-0062986; BAY-JCCP-0063000; BAY-JCCP-0448852; BAY-JCCP-0208840; BAY-JCCP-0208865 60 61 Example: Work instruction Complaint Processing WI-0330462 defines a Valid Complaint as "a complaint, which is relevant to the product itself and affects the performance of the product's intended use." The valid complaint definition is not aligned with FDA's definition of a complaint. Example: Work instruction Complaint Processing WI-0330463) defines Administrative Return events and includes packaging issues defined as "non-shipment damage". Packaging issues not related to shipping damage are potential complaints and should not be included as an Administrative Return. Example: Work instruction Complaint Capturing (WI-03429)64 identifies various sources of potential complaints; however, literature is not identified as a source and the established process does not including review ofliterature of potential complaints. Example: Bayer procedures GSOP-115, BDP- SOP 082, US03REGS-SOP-623, US03REGS - SOP 59365, establish a process in which reported events are triaged and identified as either a Technical Complaint / Product Technical Complaint (PTC), Adverse Event, or Usability Issue. Technical Complaints do not include issues related to: usability, customer satisfaction, product handling, incorrect preparation or use, or adverse events not directly associated with potential product quality issue. Each of these situations should be handled as a complaint as defined by FDA. Example: Procedures BDP- SOP 082, US03REGS - SOP-593, SOP-3351), WI-3640, WI3635, US03REGS-SOP-608, GSOP-115 (rev 5)66 define Usability Issues as events that are related to customer satisfaction or handling. The process for handling Usability Issues is inadequate and does not satisfy the requirements for complaint handling in that usability issues are treated as a report of non-defective 62 BAY-JCCP-0067643; BAY-JCCP-0062668; BAY-JCCP-0062685; BAY-JCCP-0062702 Id. 64 AY-JCCP-0085308; BAY-JCCP-u0J53D3 65 BAY-JCCP-0066289; BAY-JCCP-0066324; BAY-JCCP-2271811; BAY-JCCP-0549824; BAY-JCCP-5578094; BAY-JCCP0066359; BAY-JCCP-0066373; BAY-JCCP-0066387; BAY-JCCP-0066402; BAY-JCCP-0138079; BAY-JCCP-0138085; BAYJCCP-0138091 66 BAY-JCCP-0549824; BAY-JCCP-5578094; BAY-JCCP-0138079; BAY-JCCP-0138085; BAY-JCCP-0138091; BAY-JCCP0063163; BAY-JCCP-0063168 ; BAY-JCCP-0063173; BAY-JCCP-0063179; BAY-JCCP-0063186; BAY-JCCP-0063193; BAYJCCP-0063200; BAY-JCCP-0063208; BAY-JCCP-0564291; BAY-JCCP-0140200; BAY-JCCP-0140208; BAY-JCCP-0140216; BAY-JCCP-2272465; BAY-JCCP-0064128; BAY-JCCP-0064135; BAY-JCCP-0064142; BAY-JCCP-0063797; BAY-JCCP0063809; BAY-JCCP-0063828; BAY-JCCP-0063848; BAY-JCCP-0063867; BAY-JCCP-0063886; BAY-JCCP-0063905; BAYJCCP-0063924; BAY-JCCP-0063943; BAY-JCCP-0063964; BAY-JCCP-0063985; BAY-JCCP-0064008; BAY-JCCP-0064032; BAY-JCCP-0064056; BAY-JCCP-0064070; BAY-JCCP-0064084; BAY-JCCP-0064098; BAY-JCCP-0064113; BAY-JCCP0137957; BAY-JCCP-0137970; BAY-JCCP-0137983; BAY-JCCP-0066289 61 62 product, MDR reportability is not assessed, and an investigation is not considered. Usability Issues meet FDA's definition of a complaint. Example: Malfunctions are not adequately defined or identified in procedure SOP1630. Prior to revision J, an IVIDR reportable event was not defined. Starting at revision J, a definition was incorporated; however, no specific content such as requirements for identification, handling, or reporting were defined. In addition, the associated work instruction WI-330667 (established in March 2009) was also missing this content. GAP 2: Inappropriate and missing requirements for opening a complaint Example: Work Instructions Complaint Capturing (Conceptus) WI-342968 and Processing Essure® PTC Requests (Bayer) WI-3600 (rev D) 69 require specific criteria be available in order to open a complaint record: • An identifiable patient • An identifiable reporter • Essure® mentioned by name or enough information to reasonably identify the product as Essure® • Report of unintended side effort or adverse event If the criteria are not met, a complaint record is not opened even when the information satisfies FDA's definition of a complaint. Example: The manufacturers' procedures do not include requirements to open one complaint for each device or patient associated with an event. When this requirement has not been established, trending and monitoring of complaints is inaccurate and under reports the frequency of complaints and reportable events. Example: The manufacturer's procedures do not include requirements for recording, evaluating, and investigating a voluntary report. GAP 3: Oral complaint requirements not established Example: Procedures Product Returns, Complaint Handling and Reporting (SOP-1630) and Essure® Complaint Handling (SOP-03351)70 do not establish a requirement that oral complaints shall be documented upon receipt. 67 BAY-JCCP-0062859 BAY-JCCP-0085303; BAY-JCCP-0085308 69 BAY-JCCP-0270744 70 BAY-JCCP-0062875; BAY-JCCP-0063216; BAY-JCCP-0194281; BAY-JCCP-0196680; BAY-JCCP-0197669; BAY-JCCP0525278; BAY-JCCP-0085106; BAY-JCCP-0062888; BAY-JCCP-0062899; BAY-JCCP-0062909; BAY-JCCP-0062921; BAYJCCP-0062933 ; BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-006325 1; BAY-JCCP-0062986; BAY-JCCP-0063000; BAY-JCCP-0448852; BAY-JCCP-0208840; BAY-JCCP-0208865; BAY-JCCP-1064506; BAY-JCCP68 63 GAP 4: A formally designated unit for receiving, reviewing, and evaluating complaints is not defined Example: Procedures Essure® Complaint Handling (SOP-03351) BPD-SOP-082, BDPSOP-017, BHC-RD-SOP-013, and US03REGS-SOP00062371 do not identify one group or unit that is responsible for coordinating complaint handling functions for the Essure® product.72 ii. Evaluation (for investigation) The procedure SOP-163073 does not include adequate guidance for evaluating a complaint to determine the depth and breadth of investigation required. In addition, SOP-1630 versions E to H did not contain requirements to maintain a record that includes the reason no investigation was made for the complaint and the name of the individual responsible for the decision not to investigate. iii. MDR Reportability Assessment and Submission FDA regulation 21 CFR Part 820.198(a)(3) requires that complaints be evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting. The following table identifies the various MOR assessment methods used by the manufacturers to evaluate MOR reportability. I identified non-compliances in each method reviewed except for R3188 (identified by *). This table is followed by the gaps I identified between what is required by 21 CFR 820.198(a)(3) and what was included in the documents reviewed. 0216249; BAY-JCCP-0210778; BAY-JCCP-0205114; BAY-JCCP-0063163; BAY-JCCP-0063168; BAY-JCCP-0063173; BAYJCCP-0063179; BAY-JCCP-0063186; BAY-JCCP-0063193; BAY-JCCP-0063200; BAY-JCCP-0063208; BAY-JCCP-0564291; BAY-JCCP-0140200; BAY-JCCP-0140208; BAY-JCCP-0140216; BAY-JCCP-2272465 71 BAY- JCCP-0063163; BAY-JCCP-0063168; BAY-JCCP-0063173; BAY-JCCP-0063179; BAY-JCCP-0063186; BAY-JCCP0063193; BAY-JCCP-0063200; BAY-JCCP-0063208; BAY-JCCP-0564291; BAY-JCCP-0140200; BAY-JCCP-0140208; BAYJCCP-0140216; BAY-JCCP-2272465; BAY-JCCP-0549824; BAY-JCCP-5578094; BAY-JCCP-0692929; BAY-JCCP-0692932; BAY-JCCP-2471288; BAY-JCCP-2463900; BAY-JCCP-2620182; BAY-JCCP-0672612; BAY-JCCP-1541190; BAY-JCCP0397556; BAY-JCCP-0067911; BAY-JCCP-5566923; BAY-JCCP-0066551; BAY-JCCP-0066583; BAY-JCCP-0068042; BAYJCCP-0065531; BAY-JCCP-0066359; BAY-JCCP-0066373; BAY-JCCP-0066387; BAY-JCCP-0066402 72 F DA expectation described in 21 CFR Part 820 preamble 73 BAY-JCCP-0062875; BAY-JCCP-0063216; BAY-JCCP-0194281; BAY-JCCP-0196680; BAY-JCCP -0197669; BAY-JCCP0525278; BAY-JCCP-0085106; BAY-JCCP-0062888; BAY-JCCP-0062899; BAY-JCCP-0062909; BAY-JCCP-0062921; BAYJCCP-0062933; BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-0063251; BAY-JCCP-0062986; BAY-JCCP-0063000; BAY-JCCP-0448852; BAY-JCCP-0208840; BAY-JCCP-0208865; BAY-JCCP-1064506; BAY-JCCP0216249; BAY-JCCP-0210778; BAY-JCCP-0205114 64 Overall, the manufacturers' processes did not contain adequate content on how to determine and evaluate an event for reportability specific to Essure®, e.g. what is a serious injury, reportable adverse event, malfunction. Also, the procedures do not contain content on what to report and are limited to establishing timing requirements and general information on completing an FDA 3500A MedWatch form. These non-compliances contributed to inconsistent and inappropriate reportability decisions made by both Conceptus and Bayer. This resulted in under-reporting adverse event and malfunction MDRs to the FDA. Table 21 QMS-MDR Assessment and Report Submission Document and Revision Released Utilizes EtoK 8/2003 RA-1001 LtoZ 6/2005 QAF-2729 SOP-1630 QAF-2729 AA 12/2008 R3188* ABtoAE 5/2009 to 7/2011 WI-3306 WI-3306 GSOP-115 A 2/2014 BDP-SOP-082 BDP-SOP-017 SOP-3351 B 6/2014 BHC-RD-SOP-013 GSOP-115 BDP-SOP-082 BDP-SOP-017 BHC-RD-SOP-013 US03REG-SOP631 (US-SOP-015-BPD) C 8/2014 GSOP-115 BDP-SOP-082 BDP-SOP-017 BHC-RD-SOP-013 65 GAP 1: Inadequate reportability assessment and submission requirements Example; Procedures BDP-SOP-08274, BHC-RD-SOP-013 75 , and BDP-SOP-017 (revisions I to 3)76 are referenced, but do not pertain to the Essure® product, US FDA medical device reporting Example: Procedure SOP-3351 77is pharma-focused and contains definition of adverse event that is inadequate for medical devices. Example: Procedure SOP-3351 78does not contain timeliness requirements for reportability assessment or report submission. Example: Procedures SOP-3351 79, US-SOP-015-BPD (rev 1)80, and BPD-SOP-017 (rev 4) 81 contain inadequate or incorrect information related to US FDA medical device malfunctions and requirements for supplemental reporting GAP 2: Specific events are inappropriately defined as non-reportable events Example: Evaluation form RA-1001 indicates an MDR report is not required when "Information regarding the event is about a device that has been altered"82 or "If person qualified to make a medical judgment (e.g. physician, nurse, risk manager, or biomedical engineer) concludes that the device did not cause or contribute to death or serious injury, or that a malfunction would likely to cause or contribute to death or serious injury if it were to recur." 83 In both situations, a Med.Watch submission is required. Involvement of an altered device does not remove the obligation to report the event to the FDA. In addition, medical judgment alone is not sufficient qualifications for determination of reportability. 74 BAY-JCCP-0549824; BAY-JCCP-5578094 BAY-JCCP-0397556; BAY-JCCP-0067911; BAY-JCCP-5566923; BAY-JCCP-0066551; BAY-JCCP-0066583; BAY-JCCP0068042; BAY-JCCP-0065531 76 BAY-JCCP-0692929; BAY-JCCP-0692932; BAY-JCCP-24 71288 77 BAY- JCCP-0063163; BAY-JCCP-0063168; BAY-JCCP-0063173; BAY-JCCP-0063179; BAY-JCCP-0063186; BAY-JCCP0063193; BAY-JCCP-0063200; BAY-JCCP-0063208; BAY-JCCP-0564291; BAY-JCCP-0140200; BAY-JCCP-0140208; BAYJCCP-0140216; BAY-JCCP-2272465 18 Id. 79 Id. 80 BAY·-JC~P,0il62~()7 81 BAY-JCCP-2463900 82 RA\ -!CC1>-006~054 83 Id. 75 66 Example: Evaluation form QAF-2729 does not include adequate instruction on the use ofthe form (rev Band C)84. Revision D 85 of the form incorporated instructions into the form; however, information is lacking on how to identify malfunctions, access "likely to cause", or identify serious injury. Example: Procedure BPD-SOP-017 (rev 4)86 inappropriately identifies cases where reporting is not required for situations where a device deficiency is "always detected prior to its use", " ... shelf life of the device is expired", "expected or foreseeable side effects", or "incidents where the risk of a death or serious deterioration in state of health has been quantified and found to be negligibly small." Example: Procedure BPD-SOP-017 (rev 4)87 inappropriately requires the patient and the reporter be identifiable in order for the case to be evaluated for reportability. Example: Procedure BPD-SOP-017 (rev 4) 88 requires that a lot number be available with social media, news media, and/or literature reports in order for the complaint to be assessed for reportability. GAP 3: Insufficient documentation is requiredfor non-reportability assessments Example: Procedures SOP-1630, SOP-3351, and Wl-3306 89 do not require that the rationale for selections made during a reportability assessment be documented. GAP 4: Insufficient reportability decision documentation requirements Example: WI-3306 (rev A to C)90 states that the Regulatory group makes reportability decision after receiving a completed decision tree. Upon review, if Regulatory believes the complaint is not reportable, a new DT document is created by coordinator (not Regulatory). The procedure does not specify if the original form is retained. 84 BAY-JCCP-0085097; BAY-JCCP-0085102 BAY-JCCP-0085104 86 BAY-JCCP-2463900 81 Id. 88 Id. 89 BAY-JCCP-0062875; BAY-JCCP-0063216; BAY-JCCP-0194281; BAY-JCCP-0196680; BAY-JCCP-0197669; BAY-JCCP0525278; BAY-JCCP-0085106; BAY-JCCP-0062888; BAY-JCCP-0062899; BAY-JCCP-0062909; BAY-JCCP-0062921; BAYJCCP-0062933; BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-0063251; BAY-JCCP-0062986; BAY-JCCP-0063000; BAY-JCCP-0448852; BAY-JCCP-0208840; BAY-JCCP-0208865; BAY-JCCP-1064506; BAY-JCCP0216249; BAY-JCCP-0210778; BAY-JCCP-0205114; BAY- JCCP-0063163; BAY-JCCP-0063168; BAY-JCCP-0063173; BAYJCCP-0063179; BAY-JCCP-0063186; BAY-JCCP-0063193; BAY-JCCP-0063200; BAY-JCCP-0063208; BAY-JCCP-0564291; BAY-JCCP-0140200; BAY-JCCP-0140208; BAY-JCCP-0140216; BAY-JCCP-2272465; BAY-JCCP-0062859; BAY-JCCP0062729; BAY-JCCP-0062737; BAY-JCCP-0062867; BAY-JCCP-0062745; BAY-JCCP -0062754; BAY-JCCP-0062763; BAYJCCP-0062771 90 BAY-JCCP-0062859; BAY-JCCP-0062729; BAY-JCCP-0062737 85 67 Example: WI-3306 (rev A to D)91 does not specify who makes the final reportability decision and does not include requirement to retain approval of MDR decision. iv. Investigation FDA regulation 21 CFR Part 820.198(b) requires that complaints be reviewed and evaluated to determine whether an investigation is necessary. Duplicative investigations are not required as long as the complaint record demonstrates that the same type of failure has already been investigated. Regulations also require that when an investigation is not conducted, the reason for no investigation must be documented. FDA regulation 21 CFR Part 820.198(c) requires any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be investigated, unless such investigation has already been performed. The following list identifies gaps between what is required by 21 CFR 820.198(b) and (c) and what was included in the documents reviewed. I identified non-compliances in each method reviewed except for QAF-2291 and RA-1003 (identified by*). This table is followed by the gaps I identified between what is required by 21 CFR 820.198(b-c) and what was included in the documents reviewed. Overall, the m anufacturers processes did not contain adequate content on when an investigation was required, what the minimum requirements for an adequate investigation were, or how to perform an adequate investigation when a device was not returned or when an event reported by a complainant did not include an alleged malfunction of the physical Essure® device. Table 22 Complaint Investigation Document and Revision EtoH JandK LtoY SOP-1630 AA AB to AB Released Utilizes 8/2003 1/2005 6/2005 12/2008 QAF-2291* 5/2009 to 7/2011 RA-1003* QAF-2732 R3186 QAF-2732 R3186 WI-3640 GSOP-115 SOP-3351 Ato F 2/2014 BDP-SOP-082 WI-3635 WI-3488 91 BAY-JCCP-0062859; BAY-JCCP-0062729; BAY-JCCP-0062737; BAY-JCCP-0062867 68 Complaint Investigation WI-3366 GAP 1: An investigation was not required for all complaints Example: Bayer Directive GSOP-11592 includes a statement that "if no samples are available and no batch data of the medicinal product have been reported in the complaint, it is closed without further investigation." Additionally, procedure R3186 (all revisions) states that no investigation is required when no product is returned. This approach is not appropriate for medical device in that an investigation can be performed without requiring the return of the physical product. Example: Procedure R3186 (A, B, C, D)93 Event Investigation requires complaint file closure without conducting an investigation if product is not returned in 28 days or if product has been discarded. Example: Procedure WI-3640 (rev A and C)94 only requires the investigation of usability issues if associated with an adverse event. All complaints must be investigated unless a decision is made to not conduct an investigation as required by FDA 21 CFR Part 820.198(b). Example: Procedure Essure Case Review (WI-3640 rev A-C) 95 requires that ''there must be a direct correlation between the use of the product and the adverse event" in order to investigate the reported event. Direct correlation is not required by 820.198(b). Example: Conceptus established a technical justification (TJ-03310 Technical Justification for the waiver of laboratory investigation for clinical complaints) 96 to eliminate returned device investigation for clinical complaints. The justification was based upon an assessment of 2009 clinical complaints to detennine "whether or not laboratory investigation activities performed on associated returned product was a value-added activity." The approach to determine if the investigation activity is "value-added" is not appropriate nor is the rationale to discontinue conducting investigations. FDA 21 CFR Part 820.198(c) requires an investigation of each complaint unless a similar 92 BAY-JCCP-0066289; BAY-JCCP-0066324; BAY-JCCP-2271811 BAY-JCCP-0063314; BAY-JCCP-0063318; BAY-JCCP-0063323; BAY-JCCP-0063328 94 BAY-JCCP-0064128; BAY-JCCP-0064142 95 BAY-JCCP-0064128; BAY-JCCP-0064135; BAY-JCCP-0064142 96 BAY-JCCP-0138222 93 69 complaint has already been investigated and another investigation is not necessary. The technical justification does not satisfy these requirements. Example: Procedure Processing of Technical Complaints SOP-608 (Rev 1 and 2)97 does not require investigation of clinical complaints. GAP 2: MDR-speci.fic investigation requirements are not established Example: Procedures (SOP-1630, SOP-3351, GSOP-115, WI-3304, R3186)98 do not contain requirements defined in 21 CFR 820 .198(d)( 1-3) to determine whether the device failed to meet specification, was being used for treatment or diagnosis, and the relationship, if any, of the device to the reported incident or adverse event GAP 3: Inadequate complaint investigation requirements Example: Procedures SOP-163099 and WI-3488 100 contain limited investigation requirements which are limited to returned device with minimal activities (such as visual/measurements). Example: Procedure SOP-1630 (rev A) 101 does not address requirements for handling any "new information" that is derived from an investigation. Example: Procedure R3186 102 contains investigation requirements that focus solely on returned product. If the device is not returned in 14 days, the procedure requires the complaint remain open for another 14 days and if the device is not returned, then the complaint is closed with a reason for closure "Product Not Returned". 97 BAY-JCCP-0137957; BAY-JCCP-0137970 BAY-JCCP-0066289; BAY-JCCP-0066324; BAY-JCCP-2271811; BAY-JCCP-0062875; BAY-JCCP-0063216; BAY-JCCP0194281; BAY-JCCP-0196680; BAY-JCCP-0197669; BAY-JCCP-0525278; BAY-JCCP-0085106; BAY-JCCP-0062888; BAYJCCP-0062899; BAY-JCCP-0062909; BAY-JCCP-0062921; BAY-JCCP-0062933; BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-0063251; BAY-JCCP-0062986; BAY-JCCP-0063000; BAY-JCCP-0448852; BAY-JCCP0208840; BAY-JCCP-0208865; BAY-JCCP-1064506; BAY-JCCP-0216249; BAY-JCCP-0210778; BAY-JCCP-0205114; BAYJCCP-0063163; BAY-JCCP-0063168; BAY-JCCP-0063173; BAY-JCCP-0063179; BAY-JCCP-0063186; BAY-JCCP-0063193; BAY-JCCP-0063200; BAY-JCCP-0063208; BAY-JCCP-0564291; BAY-JCCP-0140200; BAY-JCCP-0140208; BAY-JCCP0140216; BAY-JCCP-2272465; BAY-JCCP-0063314; BAY-JCCP-0063318; - BAY-JCCP-0063323; BAY-JCCP-0063328; BAY-JCCP-0063334; BAY-JCCP-0062832; BAY-JCCP-0529721; BAY-JCCP-0062842; BAY-JCCP-0062668; BAY-JCCP0062685; BAY-JCCP-0062702; BAY-JCCP-0062718 99 BAY-JCCP-0062875; BAY-JCCP-0063216; BAY-JCCP-0194281; BAY-JCCP-0196680; BAY-JCCP-0197669; BAY-JCCP0525278; BAY-JCCP-0085106; BAY-JCCP-0062888; BAY-JCCP-0062899; BAY-JCCP-0062909; BAY-JCCP-0062921; BAYJCCP-0062933; BAY-JCCP-0420430; BAY-JCCP-0062959; BAY-JCCP-0062971; BAY-JCCP-0063251; BAY-JCCP-0062986; BAY-JCCP-0063000; BAY-JCCP-0448852; BAY-JCCP-0208840; BAY-JCCP-0208865; BAY-JCCP-1064506; BAY-JCCP0216249; BAY-JCCP-0210778; BAY-JCCP-0205114 ioo BAY-JCCP-0063501; BAY-JCCP-0063521; BAY-JCCP-0063539; BAY-JCCP-0063557; BAY-JCCP-0063577 101 BAY-JCCP-0062875 102 BAY-JCCP-0063314; BAY-JCCP-0063318; - BAY-JCCP-0063323; BAY-JCCP-0063328; BAY-JCCP-0063334 98 70 Example: R3186103 and QAF-2732 104 contain limited required investigation activities and do not include: DHR review (including OEM/suppliers) Evaluation of user/use error Risk management file review Previous related events (historical review) Device design No direction on activities to perform when not returned o Same/similar product consideration o Product trending (Previous Related Events) Gap 4: Inadequate requirements for investigation's inspection methods Example: Work instruction WI-3366 105 establishes requirements for development, implementation, and approval of new inspection methods to be used by Product Surveillance for complaint investigations. The work instruction does not require the method be qualified (or validated) prior to release. Gap 5: Inadequate flow down of investigation requirements from Bayer directive to global, USA, or Essure®-specific procedure. Bayer directive GSOP-115 establishes specific requirements for investigation report schedule, extensions, and preliminary investigation reports. These requirements were not found in SOP-3351 106, BDP-SOP-082107 , WI-3488 108 , or WI-3635 109. Gap 6: Inappropriate Root Cause Conclusion Example: Bayer directive GSOP-115 110established that the conclusion of a complaint investigation (e.g. confirmed or unconfirmed) is based on the company's responsibility for the reported problem, rather than identification of root cause. Root cause determination is independent of who is responsible for the problem. 103 Jd. 104 BAY-JCCP-0066142; BAY-JCCP-0066109; BAY-JCCP-0066137; BAY-JCCP-0066138; BAY-JCCP-0066139; BAY-JCCP0079156; BAY-JCCP-0079157; BAY-JCCP-0079159; BAY-JCCP-0079161; BAY-JCCP-0079163; BAY-JCCP-0079166 105 BAY-JCCP-0063470; BAY-JCCP-0063474 106 BAY- JCCP-0063163; BAY-JCCP-0063 I 68; BAY-JCCP-0063173; BAY-JCCP-0063179; BAY-JCCP-0063186; BAY-JCCP0063193; BAY-JCCP-0063200; BAY-JCCP-0063208; BAY-JCCP-0564291; BAY-JCCP-0140200; BAY-JCCP-0140208; BAYJCCP-0140216; BAY-JCCP-2272465 107 BAY-JCCP-0066289; BAY-JCCP-0066324; BAY-JCCP-2271811 JOS BAY-JCCP-0063501; BAY-JCCP-0063521; BAY-JCCP-0063539; BAY-JCCP-0063557; BAY-JCCP-0063577 109 BAY-JCCP-0063797; BAY-JCCP-0063809; BAY-JCCP-0063828; BAY-JCCP-0063848; BAY-JCCP-0063867; BAY-JCCP0063886; BAY-JCCP-0063905; BAY-JCCP-0063924; BAY-JCCP-0063943; BAY-JCCP-0063964; BAY-JCCP-0063985; BAYJCCP-0064008; BAY-JCCP-0064032; BAY-JCCP-0064056; BAY-JCCP-0064070; BAY-JCCP-0064084; BAY-JCCP-0064098; BAY-JCCP-0064113 110 BAY-JCCP-0066289; BAY-JCCP-0066324; BAY-JCCP-2271811 71 v. Action None of the procedures I reviewed included adequate guidance for determining when action was required for a complaint to prevent a recurrence or reduce clinical risk. vi. Closure 21CFR 820.180 requires complaint files to be maintained, to be readily available for review, to be legible and stored to minimize deterioration and to prevent loss. The manufacturers' procedures did not include requirements to ensure compliance to 21CFR820.180. They did not include requirements for ensuring complaint files were complete prior to closure, that open action items were resolved prior to closure, that good documentation practices were adhered to, that conclusions and rationale were adequately supported, and the complaint record was maintained to prevent loss. VIII. SYSTEMIC FAILURES OF THE MANUFACTURE'S POST MARKET SURVEILLANCE SYSTEM Post market surveillance reports (PMSR) which provide complaint related trend information, were generated by Conceptus between 2002 and 2013. Similarly, Global Pharmacovigilance Periodic Trend Analysis Reports (GPPT) were generated by Bayer from the fourth quarter of 2013 through 2015. PMSR and GPPT reports from each year were reviewed and gaps were identified and summarized. These results are detailed below. A. Conceptus Post-Market Surveillance system included inherent weaknesses Conceptus maintained a consistent format and overall content of the PMSR throughout their ownership. However, Conceptus changed their complaint procedures, definitions, and systems over time (reference Table 20 and Figure 22 in Section VII on Gap Analysis). This makes it difficult to compare trends over time and potentially masked trends requiring investigation, action, or reporting to the FDA. One example of significant changes to definitions occurred in 2005 when issues such as bent tips, introducer damage and tip stretch were considered Procedural Observations rather than Complaintslll and Procedural Observations did not require complaint investigations. This position is not compliant to 21 CFR 820. Specifically, 21 CFR §820.3(b) defines a complaint as "any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution." And 21CFR820.198(c) requires any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary shall be reviewed, evaluated, and investigated. 112 Ill PMSR Q4-2005 , Page BAY-JCCP-0084302. 112 Section VII B i Gap I. 72 Based upon our review of the records, the following observations were noted about the Conceptus PMSR process over time: • Reporting on MDRs was added to the PMSR in 2004. • In 2006, user errors were added as a category of complaints. This category was defmed as incidents that are addressed in the IFU and training documentation. "While these incidents would not typically necessitate an AR, many of these were reported by representatives as part of the documentation process for replacement of Field Inventory." 113 • Changes to the Risk Management criteria and Risk Priority Numbers were made in 2005 and 2006 due to changes in the Risk Management Procedure114 and the Product Return, Complaint Handling and Reporting Procedure11 5; therefore, the risk levels for failure modes defined in Design Failure Mode Effect Analysis, DR-020, were revised in Ql-2006 with the potential of modifying how various failures were mitigated. 116 After 2012, Statistical Process Control (SPC) criteria defined in WI-03490, Statistical Monitoring of Complaint Metrics were required, however not consistently followed. This work instruction requires use of traditional SPC rules including none (or more) points in a row are on the same side of the mean could indicate a shift in the process mean117 and as shown in Figure 23 below, trends meeting these criteria occurred. At times, these trends were not investigated to determine the source of the anomaly. When no investigation occurred to determine the source of the anomaly then no action could be made to prevent a recurrence. m BAY-JCCP-0084388 at 96 114 BAY-JCCP-0227514 us BAY-JCCP 0 0082472 116 117 BAY-JCCP-0084301 BAY-JCCP-0063604 73 ~ a:: -· . - ·- ? -a 0.10'¾, C) 0.0517c; .. e 0 Mcnth Figure 23 118 The manufac turers did perform trending periodica lly as required in 21 CFR Additionally, Annual Reports and Annual Report Amendm ents were submitte d t shown in Table 23 below. Details relating to Annual Reports follow the table. Table 23 PMSR, GPPT, Annual Reports, and Annual Report Amendment, 1 2 No Yes No Yes 120 Yes Yes Yes 4119 4 4 4 4 118 1 0 2 0 2 2 2 BAY-JCCP-0086598 Reports from 2004-2012 were consistently performed by Conceptus at approximately quarterly intervals. 120 No report was submitted by Conceptus that covers data from Jan I, 2004 - Dec 4, 2004. The 2004 report s; Dec 2004 - 6 Jan 2006. 119 74 4 4 4 4 Q l-Q3 Conceptus & Q4 Bayer121 4 Bayer- 2 PTC & 2 GPPT 4 Baver- 4 GPPT Yes Yes Yes Yes Yes 1 0 0 1 1 Yes Yes 1 0 The PMSRs from Q2 of 2005 through the third quarter of 2013 included a distribution list. The listing demonstrated that Top Management as well as departmental management were aware or should have been aware of complaints, field actions and quality system performance including the complaint handling and :MDR reporting processes. fu. accordance with the work instruction Statistical Monitoring of Complaint Metrics WI-03490122, "on a quarterly basis a post market surveillance report will be distributed to regulatory, quality engineering and executive management, and is considered input to management review." 123 The individuals listed in Table 24 were copied on the distribution of the quarterly reports. Based upon my review ofthe documents that follows, I did not find any evidence that this awareness resulted in effective actions to address the known trends. 124 Selected individuals copied on reports included: »· T able 24 SeIect ed 1st n"bu tion L.ISt tior PMSR C oncep t us Name Title Year(s) Individual on Staff Mark Sieckarek President and CEO 2002-2011 QC Product Surveillance Lois Pierce Unknown Manager VP/ Director Clinical Edward Yu 2006-2009 Research, Regulatory Affairs EVP, CFO & Treasure, VP Kristen Lichtwardt 2009-unknown Ops, QA and QE Jeff Letasse Not available 2005- unknown Chris Stout Director R&D Unknown MSN, NP, Clinical Project Pam.Price Unknown-2011 Manager 121 Reports in 2013 include Conceptus device and clinical complaints and a Q4 Bayer report in regarding product technical complaints (PTC). 122 BAY-JCCP-0063604. 123 Ibid, pg.2. 75 Name Rob McCarthy Todd Sloan David Haan Rachelle Acuna-Narvaez Title Operations Director, QE, QA VP, R&D, Strategy, Professional Marketing, & IP Director, Program Management Regulatory Affairs Manager Year(s) Individual on Staff 2001-2009 Unknown -2009 .,... ~-·· ·- - ~ Unknown ~--•»-..-· 2010-2012 The Bayer GPPT reports did not include a distribution list, therefore, it is not known what level of management received the data, if any. Conceptus consistently presented trend reports that included several indicators of Essure® device performance, such as: • Deployment • Detachment • Rollback • Bent tip However, the PMSRs did not include indicators related to key clinical outcomes including: • Migration • Device removal or hysterectomies • Autoimmune diseases • Perforation Furthermore, for the Conceptus-era, only one (1) failure mode was assigned per complaint, which masked the true multifaceted nature of complaints and distorted the picture of the postmarket Essure® experience. The following table represents a sample of complaints that were chosen for each year between 2002 and 2008 that were reviewed to determine if the final failure mode assigned was less serious than the injuries reported in the complaint file. As indicated below, the manufacturers' practice of assigning a single failure mode often masked more serious injuries within the complaint file. 76 Table 25 125 Year 2002 2003 2004 2005 2006 2007 2008 SUM % yes total % No total % NIA total Yes-the · failure mode masked the more serious iniurles 1 39 24 33 67 31 60 No - the failure mode did not mask the injuries within the complaint 0 N/A(No failure mode assigned by manufacturer) 0 0 0 4 0 0 Total 255 55 4 1 47 32 47 76 32 79 314 81% 18% 1% NIA NIA NIA NIA NIA NIA NIA NIA NIA 8 8 10 9 1 19 0 %Yes/ Year %No/ Year 100% 83% 75% 70% 88% 97% 76% 0% 17% 25% 21% 12% 3% 24% NIA NIA NIA NIA NIA NIA NIA NIA B. Bayer Post-Market Surveillance system did not provide for cross transition analysis Once Bayer assumed responsibility for the Essure® product, the approach to trending was changed. As seen in Figure 24 126 the reporting methods and content changed significantly under Bayer's direction. 125 Revised to be consistent with Table 9. Includes complaints that should have been reported but were not and met the criteria established by the Regulatory Experts. Reference Section VI.C.i, 126 BAY-JCCP-0086091 at BAY-JCCP-0086135. 77 4., Reporting Rate by Ev-i1nt Groupings of Special interest Legacy Data Case Grouping* Lack of Effect 01Jan13 • 30Sep13 -----Bayer Data 01 Oct13 - 30Jun14 Case Reporting Case count Rate[%) count 317 734 407 1 Pregnanc;y 170 0.29 0,16 Fcio,:,ic prttgnanr:y 5 243 o.oo 15 0 ,23 435 0.84 0,13 0.12 983 Patency Device Displar-Amant 908 142 125 Perforation £,xpulsion Al/orgk; co11rl/tinns 66 43 Infection» & tnf..stalions 325 180 Re,:>orting Rate~ 0,91 0.43' 0,02 0,54 1,22 0.40 0,22 0,06 402 0,50 0 ,04 207 0,26 41 0.,04 190 10 0.01 43 0.24 0,05 Ahc1orninal & pelvic r,ain 179 0.17 754 0.93 Procedural complications 667 0,64 603 0,75 Device complication& 83 0,08 410 0,51 DmtiCf> quality iSliUftS 306 77 0,28 0,07 404 Device brsakage 195 0,50 0,24 690 0.64 761 0,94 Hypersensniv,ty & toK1city Ptr1/vir, infJRmmatory d/seaRes Human i'actor Figure 24 Bayer 2013-2014 Complaint Occurrence Rate Based upon the differences in reporting techniques, it is not possible to draw equivalent comparisons between the two (2) methods or across the transition period between the two companies' ownership. C. Failures in Post-Market Surveillance prevented safety signals from reaching the FDA. As of April 2013, Conceptus had not included migration, device removal (hysterectomies included), autoimmune diseases, or perforation in their trending analyses. Perforation was being reported to the FDA in Annual Reports by the Conceptus regulatory organization127 , but Annual Reports are not a substitute for MDR reporting. The Annual Reports are used to support the PMA submission and are not received by the post market branch of the FDA (CDRH-OSB). The submission of an MDR report under 21 CFR803 is not exempt because the event was included in an Annual Report to FDA. 78 D. Three (3) top failure modes: bent tip, deployment difficulties and detachment difficulties, were determined to be low risk, resulting in no action over time to prevent or mitigate complaint occurrence as discussed below. I would expect the top five ( 5) failure modes to change significantly over 10 years because I would expect a company to investigate and reduce the top complaint occurrences through their corrective action process (CAPA). However, between Modes 2002 128 and 2012 complaint occurrences for the top events such as bent tips and deployment difficulties did not change. 129 i. Bent Tip Bent tip failures were routinely reported and allowed to go on for many years without an effective solution. Failures were known but not solved. Bent tips were a well-known failure mode as early as 2002-2003. In fact, bent tip was the number one reported complaint in this presentation. 130 Several root causes were identified and Conceptus documented the intent to open a CAPA to address the identified root causes. 131 In the meantime, Conceptus Professional Education function developed a bent tip work around that had Professional Educators show Physicians how to slightly re-bend the tip during the procedure132 to minimize the chance of problems related to bent tips and reduce complaints. This is considered a field corrective action according to 21CFR806 and is required to be reported to FDA if the action is being taken to return the device to specification or reduce a risk to health and it was not reported under 21CFR803. 128 9 12 BAY-JCCP-0084161. BAy -JCCP-0084810. BOBAY-JCCP-0084161 at65. BAY-JCCP-0084161 at 67. 132 Ibid. 131 79 ' # June 2002 thr!>ugh Junll 2003 7S 70 CAPA t<> be lrlltt.rted Week or July :n. Z003to address roo1 !:811$95 ofl>ent1ips ~5 tiO .. 55 .,"' :';(I C: 45 :I .. ~ <> 8 0 0 z -_-- - CAPA.02"-002 initiated to addre&s delachmllnl ;,.,_.... -- u ...-r--i;------------,,.,. 40 so 25 :lO 1~ 10 6 a In the Q4-2005 PMSR, Conceptus wrote "According to Risk Assessment FMEA DR-20 Rev 7, bent tips are categorized with a risk priority number of 54 ( Action level is defined at a RPN of 200 per SOP-01107, Rev. F3). The potential effect of this well-documented and understood issue is to necessitate use of a new device with a small increase in procedure time . . . There have been no safety concerns associated and/or reported with this failure mode. All devices in bent tip reports conformed to stated specifications. The potential effect 'is to necessitate use of a new device with a small increase in procedure time.' The largest sub-category for Bent Tip ARs continued to be 'Bent Tip - Procedure'. Included in this category are tip bends due to mishandling or interference occurring during the procedure. The second largest category for bent tips was, 'Bent Tip Anatomy', where the tip becomes bent due to contact with the uterine wall, fibroids, or during difficult cannulations." 133 These conclusions are incorrect for several reasons including: • Conceptus did not evaluate each complaint as required by 21 CFR803 to determine whether the Essure® device could cause or contribute to an injury including events occurring as a result of: (1) Failure, (2) Malfunction, 133 BAY-JCCP-0084301 at 6. 80 • • (3) hnproper or inadequate design, (4) Manufacture, (5) Labeling, or (6) User error. Conceptus did not assess whether the risk documentation should be revised based on the frequency of received complaints for bent tip. Conceptus did not investigate why the actions taken in 2003 as discussed in Post Market Surveillance Report, June 2002 through June 2003, were not taken or were not effective. Additionally, bent tips were known to occur frequently with the use of Olympus scopes. Despite the re-training, over two (2) years Conceptus was still receiving reports of physicians experiencing problems with interactions with hysteroscope. The manufacturers' Post Market Surveillance docwnented the failure to resolve issues such as bent tips. In one quarterly report, the manufacturer noted that: "Bent tip due to anatomy and procedure mishaps will still be expected due to physician inexperience in early stages of training as well as general hwnan errors, which may occur at any time, regardless of experience. A change in the physical characteristics of the tip coil may help to reduce the number of these procedural observations, and this is one of the design modifications being explored in Project Graceland."134 134 BAY-JCCP-0084301 at 8. 81 ii. Deployment Difficulties and Detachment Difficulties Continued Overtime As shown in Figure 25 above, deployment and detachment failures were well known and documented as early as 2002. In 2007, these issues were still top occurring complaints. Deployment and detachment difficulties were analyzed separately but were acknowledged as terms misunderstood by users, "As terminology may also be confusing for the users or hospital staff reporting the problem, 'Deployment' and 'Detachment' are often used synonymously and it is possible that the issues reported are not actually deployment issues."135 "Deployment difficulty complaints refer to the inability of the coils to expand after the release catheter has been fully retracted. According to Risk Assessments FMEA DR-20 Rev 7, the experienced failure mode is categorized with risk priority numbers of 90 and 105 in item 74. (Action level is defined at a RPN of 200 per SOP-01107, Rev. F4)." 136 "Detachment complaints refer to the inability to remove the delivery wire from the microinsert after it has been deployed and allowed to fully expand in the fallopian tube. According to Risk Assessments FMEA DR-20 Rev. 7, detachment failure is a known failure mode and categorized with a maximum risk priority number of 168 (Action level is defined at a RPN of200 per SOP-01107, Rev. FS)." 137 "Detachment issues still exist for our users due to the inherent fiber I wire contact as well as tubal tortuosity and other causes. To address issues related to the design of the deployment and detachment mechanism, and to simplify those portions of the procedure, redesign of those mechanism is in progress. The implementation and commercial availability ofthe new design was approved in 2007 and officially launched as the ESS 305 product line in August 2007 ." This redesign was not effective, and deployment related complaints continued to be a top failure through Q2-2014 as demonstrated by Figure 26 below. 135 BAY-JCCP-0084478 at 93. 136 Ibid. 137 BAY-JCCP-0084478 at 94. 82 FIGURE I: Parelu or Top Fin: PTC CutC'~oriic-~ Top Fivt.- DP.vie E" A~s Jui 2013 - Jun 2014 > • •• ...--- .. ~ ..,._~.. .. .. ,: t ' •• ~ •· ..... ,-..•.; . , . • -.• . ~ ·,: - l ! :- Figure 26 Q2-2014 Top 5 Device Complaints 138 The following background communications occurred between Reglera, Conceptus and the implanting Physician. The acknowledgement letter sent by Vincetta Shortino of Essure® Product Surveillance, was incorrect in that it stated, "no patient hann was done." 139 In fact, the physician replied that the statement needed ''to be changed to 'significant patient harm was done in addition to causing a failed procedure' ." 140 The physician also stated that ''this particular malfunction was significantly more egregious than other premature deployments we have had."141 A malfunction occurred causing both patient harm and medical intervention. This coupled with the fact that a small portion of the micro-insert remained in the fallopian tube and the physician planned to conduct a bilateral tubal ligation makes this a reportable event. Like deployment difficulties, detachment difficulties continued to be a top failure through Q2-2014 as demonstrated by Figure 26 above even though fiber modifications were taken to the coil catheter design in 2003. 142 138 BAY-JCCP-0086174 139 BAY-JCCP-0287682. 140 Ibid at 86. 141 142 Ibid. BAY-JCCP-0084124. 83 IX. COMPLAINT AND MDR EXPERTISE, TRAINING, AND QUALIFICATIONS FDA regulation 21CFR§820.25 defines the minimum personnel requirements for medical device manufacturers. Paragraph (a) requires the manufacturer to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. 21 CFR§820. l 98 requires the manufacturer to have a formally designated unit for receiving, reviewing, and evaluating complaints. The manufacturer can hire outside suppliers or contractors to perform parts of their complaint management process, but the manufacturer cannot delegate responsibility for compliance to FDA regulations to any supplier or contractor of complaint management services. The manufacturer must define who is the formally designated unit for complaint management and must ensure there are sufficient personnel with the necessary education, background, training, and experience to assure that all complaint management activities required by 21CFR§820.198 .tnd 21CFR§803 are correctly performed. Additionally, 21CFR§820.25 requires each manufacturer to ensure that all personnel are trained to adequately perform their assigned responsibilities including the need for personnel to be made aware of device defects which may occur from the improper performance of their specific jobs. The designated complaint management unit for a medical device has the following general complaint and MDR compliance responsibilities. These are industry best demonstrated practices and without these competencies complaint handling and MDR systems are more likely to be non-compliant based on my professional experience and expertise. Based upon my professional experience and expertise, general complaint management: • Manage complaints from initiation through closure to ensure compliant documentation and timely processing. • Communicate with complainants to gather information regarding the nature and details of the complaint as needed ( e.g. physicians, hospital personnel, sales representatives, international offices). • Evaluate product complaints to: o Verify they meet the definition of a complaint. o Determine if the nature and details of the event are adequate to further evaluate or investigate the issue. o Determine if the reported issue meets the definition of an event reportable to a global regulatory agency. o Determine the depth of investigation required for the reported issue. o Determine if a clinical review of the reported issue is needed. •, Alert management to identified potential product performance issues. • Ensure adequate complaint investigation are performed with appropriate prioritization and in a timely manner. • Ensure accurate entry of information into the complaint record. • Maintain complaint records and ensure completeness prior to closure. • Write and submit Medical Device Reports to FDA • Respond appropriately to complaint and MDR related inquiries from FDA Based upon my professional experience and expertise, Complaint Device Investigation: 84 • • • • • • • • Evaluate complaints to determine if the reported issue was previously investigated. Investigate complaints commensurate with risk associated with the reported condition. Ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements, both domestic and international. Identify complaints requiring escalation. Involve appropriate personnel (e.g. R&D, manufacturing, quality, medical affairs) in the investigation depending on the nature and severity of the complaint. Ensure timely, accurate and well documented failure investigations. Perform root cause analyses to identify plausible failure source(s) (design, manufacturing, labeling, etc.). Use root cause and failure analysis tools to enhance and support conclusions of forensic failure analysis as needed. Members of the designated complaint management unit need the following skills and competencies to execute assigned responsibilities and to ensure compliance to 21CFR§820.198 and 21CFR§803: Table 26 Complaint Manafement Unit Personnel Skills and Competencies Responsibility Skills Competencies De-escalation Oral Communication Clarity and unambiguity in discussions Identify/define problem statement All aspects of Complaint Management: Receipt, Review, Evaluation, Investigation, Escalation, and Closure Understanding Basic Problem Solving and demonstrated problem solving experience Diagnose cause Identify actions Implement actions Define/demonstrate effectiveness Understand Requirements demonstrated proficiency 21 CFR 820.198, 21 CFR 820.200, 21 CFR 820.100, 21 CFR 803, 21 CFR 806 I 21 CFR 7, and Related Local Procedures Identify required elements of Complaint Management and CAPA Understand and use Complaint database Timely submissions of appropriate records Knowledge of product, process or aualitv issue under review As assigned Gob specific) Writing for Compliance demonstrated proficiency Written Communication with Complainants 85 Responsibility SkiUi; Competencies . Creation of interim and final quality records and summaries suitable for regulatory communications, internal and external audiences. Internal Audit Experience Complaint/ Investigation Root cause analysis and Failure Investigation. Experience with diagnostic and troubleshooting tools Proficiency in auditing records to re!!l.llatorv compliance Identify numerous possible causes Effective use of tools Identify likely cause(s) Recommend action Review risk documentation Knowledge and proficiency in Risk Management (Device and Clinical) Assess adequacy Provide feedback These skills and competencies were not in evidence in the 5,182 complaints reviewed as demonstrated by the results noted earlier. Complaint backlogs as identified in the 2009 Management Review 143 represents an organization that is understaffed or under resourced (e.g. has an ineffective process, suffers from mismanagement, lack of training or competencies, insufficient personnel, poor personnel performance, or inadequate equipment). From my experience, management efforts to reduce backlogs focused on quantity over quality and result in insufficient time to ensure investigations and documentation are complete. Based upon my review of the internal policies, at times the manufacturers had an internal policy which required that each complaint was to be evaluated within three (3) days of complaint receipt to determine if reporting is required. 144 However, the manufacturers continually had "backlog" of open complaints that it failed to timely process.145 In my professional experience, a backlog can hinder full investigations, result in poorly trained staff, and this can further reduce the compliance of the complaint and MDR processes. 143 BAY-JCCP-7404743. (BAY-JCCP-0062875. 145 See Deposition of Ayesha Siddiq dated May 22, 2019 at 156:19-157:14; Deposition of Steve Yost dated September 6, 2019 at 116:19-117:23; Deposition ofRobert McCarthy dated March 19, 2019 at 108:3-23. But see Deposition ofMichael Reddick dated March 13, 2019 at 351:8-356:18; Deposition of Michael Reddick, dated April 18, 2018 at 628:15-629:19; Deposition of Edward Yu, dated September 17, 2018, at 99:24-100:22 and 101:7-22. 144 86 The following statements are taken from the referenced internal company documents to illustrate the inability of the manufacturers• complaint handling and MDR reporting systems to adequately respond to the volume of complaints received: 3/2003 - BAY-JCCP-0086507-0086524 • The second cause is the Complaint Handling system cannot adequately handle the increase in the number of complaints. 2/24/2005 -BAY-JCCP-0050198 • • • Employees have not been adequately trained. Employee training is not fully documented. Procedures for identifying training needs were not complete and implemented. 10/31/2008 - BAY-JCCP-0250290 • • • • • Complaint Handling System has open holes Failure to meet target system metrics per SOP is driven by gaps in system Insufficient staff Insufficient knowledge of requirements Reps use of CRM system 6/25/2014 - BAY-JCCP-0435843 • • Milpitas personnel were not adequately trained on the overall global complaint handling process to adequately oversee and/or explain the complaint cases. Milpitas personnel will be trained on the overall global complaint handling processes delegated to outside functions in order to adequately oversee and explain complaint cases. 6/8/2007 - BAY-JCCP-0531264 (Executive Audit Report) ,. • • Job descriptions are not being updated and do not reflect current responsibilities and authorities for key processes supporting the Quality System. SOP 404 Rev Y does not define how training effectiveness criteria is established and documented in training records. Training effectiveness was a finding in the internal audit that was conducted in March 2006 and was discussed during the Management Review meeting on (10/17/06), however, to date, corrective action has not been taken to address this finding. SOP 404 does not define requirements for ongoing / refresher Quality System training. Based on interviews that were conducted, it does not appear that resources have been allocated to ensure that Quality System training is conducted on a regular basis. Some examples ofQuality Systems that impact all areas would be the importance ofidentification, segregation and traceability to prevent inadvertent mix-ups, employee responsibilities when "becoming aware" of complaints (SOP 1630), document control, record control, training, etc. 87 Based on the above evidence in this section, I conclude the manufacturers failed to hire and designate sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by 21CFR§820.198 were correctly performed including, by reference, 21CFR§803. X. MISSED OPPORTUNITIES The manufacturers failed to respond appropriately and adequately to FDA Audits, communications, and regulations. A. Incorrect Assumptions of FDA Expectations The FDA has provided regulations and guidance to manufacturers on their minimum expectations for complaint handling and MDR reporting. For example: • • FDA 21 CFR§803.50 establishes the requirement to report to the FDA information required by §803.52 no later than 30 calendar days from the aware date of information, from any source, that reasonably suggests that a distributed device: (a) May have caused or contributed to a death or serious injury or (b) Has malfunctioned and this device or a similar distributed device would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. FDA 21 CFR§803(c) defines "caused or contributed" to mean that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of: (1) Failure, (2) Malfunction, (3) Improper or inadequate design, (4) Manufacture, (5) Labeling, or (6) User error. The FDA does not prescribe in regulations how the company must document their rationale for why their medical device did not or may not have caused or contributed to the complaint event, but 21 CFR 820.198(d) requires "Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated". In the absence of documented rationale why a device could not have caused or contributed to the event, causality is left to interpretation. Based on my professional experience, if a manufacturer does not clearly document why a complaint is not reported under 21CFR803, the FDA will presume that it is MDR reportable. This is evident in the FDA 483 issues to industry manufacturers 88 including the .l<'DA 4~3 issued to Mark M. Sieczkarek, President and CEO, on January 6, 2011, for inspection dates 12/08/2010 - 01/06/2011. 146 Unless a manufacturer establishes rationale why a certain type of complaint can be evaluated as a group, each complaint must be evaluated on its own merits. The variability in practitioners, patients, environments, manufacturing lots, and design versions make it difficult to conclude they are same without an evaluation of the nature and details of each individual complaint. If a complaint is determined to not be reportable under 21 CFR803, the manufacturer must document the decision process they followed to reach that conclusion include the rationale for why the device did not or may not have caused or contributed to the complaint event. According to the Quality System Regulation Preamble: 147 ... Section 820.198(b) discusses the initial review and evaluation ofthe complaints in order to determine if complaints are ''valid. " It is important to note that this evaluation is not the same as a complaint investigation. The evaluation is performed to determine whether the iriformation is truly a complaint or not and to detennine whether the complaint needs to be investigated or not. If the evaluation decision is not to investigate, the justification must be recorded. Section 820. l 98(c) then describes one subset ofcomplaints that must be investigated but explains that duplicative investigations are not necessary. In cases where an investigation would be duplicative, a reference to the original investigation is an acceptable justification for not conducting a second investigation. Section 820.198(d) describes another subset of complaints that must be investigated (those that meet the MDR criteria) and the information that is necessary in the record of investigation of those types of complaints. Section 820.198(e) sets out the type of information that must be recorded whenever complaints are investigated. The iriformation described in Sec. 820.198 (e)(l) through (e)(5) would most likely be attained earlier in order to perform the evaluation in Sec. 820.198(b). Similarly, an FDA inspection of a manufacturer that does not result in objectionable observations or findings does not mean that the manufacturer is operating in a state of compliance. FDA investigators sample procedures, practices, and evidence depending on the intent of the inspection. The FDA Investigations Operations Manual 2019, Chapter 5148 states: "An establishment inspection is a careful, critical, official examination of a facility to determine its compliance with the laws and regulations administered by FDA. Inspections may be used to collect evidence to document violations and to support regulatory action, when appropriate, or they may be directed to obtaining 146 BAY-JCCP-0911996. 147 https:// www. fr!a. l!o v/med icai-devices!q uaiity-svst'cm-q s-regu ia lionmedic,,.1-aevice-,~omt-TJ!anufacturi ,1g-p:actic~s/medicalc.evke,;-currcn'.-good-1na1111f;;ctu ring-praciice-cgmp-fir.3.l-n1 !<"-9 u«lit·/-s)' stc~1-regul:.; tion FDA Investigations Operations Manual 2019. Pages 5-21. https://www.fdagov/rnedia/76769/download 148 89 specific infonnation on new technologies, good commercial practices, or data for establishing food standards or other regulations. The degree and depth ofattention given various operations in a firm depends upon information desired, or upon the violations suspected or likely to be encountered. In determining the amount of attention to be given in specific cases, consider the: 1. Current Compliance Program, 2. Nature of the assignment, 3. General knowledge ofthe industry and its problems, 4. Finn history, and 5. Conditions found as the inspection progresses. " Additionally, the FDA Investigations Operations Manual, section 5.2.3.1.5 149 indicates the following language should be inserted on the FDA 483: "The observations noted in this form FDA 483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations ofthe quality system requirements. " Examples of Form FDA-483s received by Conceptus and/or Bayer with this statement include: • • • • Issued to Steven R. Bacichl President and Chief Executive Officer on July 9, 2002 for inspection dates 06/25/2002 - 07/09/2002 150 Issued to William H. Dippel, Vice President, Operations on July 7, 2003 for inspection dates 06/25/2003 - 07/07/2003 151 Issued to Mark M. Sieczkarek, President and CEO on January 6, 2011 for inspection dates 12/08/2010 - 01/06/2011 152 Issued to Philip (NMI) Brown, Vice President of Operations of VENUSA DE MEXICO (Foreign Contract Manufacturer) on February 24, 2005 for inspection dates 02/21/2005 02/24/2005153 Additionally, the Establishment Inspection Report (1000221357) 154 includes the following statement. 149 Ibid. 150 BAY-JCCP-0009255 BAY-JCCP-0523832 152 BAY-JCCP-0523829 153 BAY-JCCP-0050198 154 BAY-JCCP-0000001 1s1 90 "GENERAL DISCUSSION WITH MANAGEMENT I told the firm officials that the observations are not a complete list of all the conditions that may be in violation of the Food, Drug and Cosmetic Act. I told all firm personnel present at the close-out meeting that the firm can send their reply to the District Office. I warned them that violations ofthe FD&C Act carry the penalties of seizure, injunction, and civil penalties. " In summary, the FDA has provided numerous regulations and guidance to manufacturers on what the FDA considers their minimum expectations for complaint handling and MDR reporting. As cited above, these include the Quality _System Regulation Preamble, the FDA Investigations Operations Manual, and Establishment Inspection Reports. The FDA clearly notes in the preamble that the complaint handling and MDR regulations are "basic requirements". 155 B. FDA Communications on Perforations and Pregnancy Conceptus missed opportunities to adjust their practices and procedures to align with FDA expectations and to clarify their understanding of FDA regulations. For example, they communicated directly with FDA Office of Surveillance and Biometrics (FDA-OSB) on Medical Device Reporting of pregnancy and perforation related complaints beginning in 2004 but did not adjust their reporting practices when FDA provided specific guidance. The FDA-OSB establishes MDR reporting policy, evaluates submitted MDRs for compliance to regulations, and monitors post market events to identify problems with medical devices. i .. Medical Device Reporting of Perforations 156 On February 10, 2004, FDA-OSB notified Conceptus they considered tubal perforations to be MDR-reportable events. 157 Conceptus did not alter their reporting practices but replied to FDAOSB that Conceptus did not agree. 158 On May 3, 2004, FDA-OSB again responded that they considered fallopian tube perforations in patients relying on the Essure® device to be MDR reportable. 159 Conceptus again did not alter their reporting practices on perforations. Prior to May 28, 2004, FDA-OSB sent a letter to Conceptus seeking additional information related to voluntary MedWatch report MWl 031305 received by FDA-OSB February 19, 2004 160, that reported uterine 155 FR Doc. 96-25720, comment 198 BAY-JCCP-0912073 157 BAY-JCCP-0912075 158 BAY-JCCP-0912077 159 BAY-JCCP-0912096 160 BAY-JCCP-1637076 156 91 perforation/s. The FDA-OSB specifically asked Conceptus to describe reports they had received for fallopian tube perforations. FDA-OSB again states they consider fallopian tube perforation by the Essure® device to be MDR reportable. On May 28, 2004, Conceptus responded to the FDAOSB request for additional information that Conceptus did not consider perforations to be MDR reportable. 161 On August 10, 2004, Conceptm contacted FDA-OSB by phone and followed up with an e-mail providing FDA-OSB with the Conceptus communication of May 28, 2004, that included the justification for not reporting certain types of uterine and fallopian tube perforations. 162 On September 15, 2004, Conceptus e-mailed FDA-OSB to follow-up stating, "I know this is not a high priority but I would like to resolve the MDR categorization issues at some point."163 By this time, Conceptus had been knowingly not meeting FDA-OSB expectations regarding the MDR reporting of perforations for seven (7) months. FDA-OSB replied on September 24, 2004, that "Basically, we agreed with your assessment of your MDR obligations for the events cited in Ms. Dwyer's letter to your firm ... " 164 regarding the Conceptus assessment of their reporting obligations with respect to the events cited in the May 28, 2004, communication and that FDA-OSB was drafting a letter to Conceptus to explain their reasons for this determination. This response from FDA was specific to "events cited in the May 28, 2004" and was incorrectly interpreted by Conceptus to mean a broad acceptance of the Conceptus rationale for not reporting certain types of uterine and fallopian tube perforations. FDAO SB did not clarify what was meant by "Basically, we agree ... " and indicated explanations for their decision would be communicated via letter. Conceptus did not wait for receipt of the formal letter of explanation and again did not alter their reporting practices for perforations. Conceptus did not follow-up with FDA-OSB regarding the receipt of FDA's formal letter of explanation until October 7, 2008,165 and then performed another follow-up with FDA on November 10, 2008. 166 On November 14, 2008, FDA-OSB replies the letter was never finalized and that if they completed it present day the answers could only be applied to the period addressed in the original correspondence between Conceptus and FDA-OSB in 2004. 167 In this correspondence, FDA-OSB states any answers to the original questions may not apply to any newer information or event situations. Conceptus did not alter their reporting practices and continued to rely on the September 24, 2004 e-mail as supporting evidence for not reporting. In the complaints we sampled between May 29, 2004, and November 10, 2008, there were 260 complaints associated with perforations that were not reported and four ( 4) that were. 161 BAY-JCCP-1029339 BAY-JCCP-0038735 R 163 Id.. t64 Id. t65 Id. 166 BAY -JCCP-0017541 t67 Id.. 162 92 Conceptus did not follow up with FDA-OSB regarding the letter again until April 23, 2009, when they asked for documentation from FDA stating the previously promised letter would not be provided. 168 FDA-OSB replied on this date that they were reviewing MDRs Conceptus had filed since Essure® was approved for marketing to determine if there are any other MDR reporting issues that need to be included in the letter. 169 This statement should have been a red flag to Conceptus that FDA-OSB had Essure® MDR reporting concerns. On July 17, 2009, Conceptus issued a Regulatory Memo to file 170 stating that only perforations caused by the Essure® device and requiring intervention were reportable specifically referencing the September 24, 2004, e-mail from FDA-OSB as the supporting rationale. Causality does not have to be proven and intervention is not required for a complaint to meet the reporting requirements of 21CFR803. Once a serious injury has occurred because of a perforation that wasor may have caused or contributed by the Essure® device, the likelihood that a perforation caused or contributed to by the Essure® device would cause or contribute to a serious injury is presumed. These cases are required to be reported to FDA as malfunction MDRs until likelihood is disproven. On January 6, 2011, FDA issued a Form FDA-483 171 to Conceptus with observations that Conceptus did not report adverse event MDRs for three (3) perforations (Observation I) and did not report malfunction MDRs for five (5) complaints (Observation 2). On January 12, 2011, Conceptus e-mailed FDA-OSB requesting a conference to discuss MDR reporting of perforations and the interactions the FDA investigator had with FDA-OSB during the inspection. Conceptus filed one (I) MDR for the third complaint listed under Observation 1 in response to the Form FDA-483. This MDR was received by FDA on January 17, 2011. Conceptus added notes to the other two (2) complaints under observation 1 stating the perforation was caused by a different manufacturer's scope. On January 20, 2011, in response to the Form FDA-483, Conceptus committed to notifying other device manufacturers when they received notification of a perforation caused by another manufacturer's device. 172 The two (2) complaints referenced in Observation 1 that Conceptus did not file MDRs for do not include evidence that the other device manufacturers were notified that their devices may have caused or contributed to a serious injury. In one (1) case the patient was hospitalized. 168 Id. 169 Id. 170 BAY-JCCP-0440014. BAY-JCCP-0911996. 172 BAY-JCCP-0911999. 171 93 On February 8, 2011, FDA-OSB sent a formal letter to Conceptus, In this letter FDA-OSB states that perforations are a serious injury ifmedical or surgical intervention was required whether it is due to a malfunction or a user error. 173 Additionally, FDA-OSB states a perforation would be a reportable malfunction if the malfunction would be likely to cause or contribute to a serious injury were ii: to recur. 174 FDA defines malfunction as "the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed." Conceptus again does not alter their reporting practices to include malfunction MDRs for perforations. Based upon my review of the policies, Conceptus inconsistently defined malfunction in their procedures, and they did not establish reporting practices for malfunction MDRs. Of the 222 complaints I reviewed in the sample set, 16 were related to perforations (2002 - 2015). Four (4) ofthese were reported as MDRs. The other 12 should have been reported. Ten ofthese specified some type of intervention or injury in the complaint record. The other two (2) that did not specify intervention occurred in 2004 and 2015 after a precedent setting event. In the Regulatory Memo, MDR Reportability of Pregnancies and Perforations, dated March 16, 2012, 175 Conceptus documents their inference that the letter they received from FDA's Office of Compliance on May 10, 2011, noting ·Conceptus' s proposed corrective actions in response to the Form FDA-483 should adequately address the audit observations. Inferring any fact from an implicit statement in an FDA letter is a risk-based decision. ii. In November 2014, Bayer issued Essure MDR Reporting standards. 176 This document provides requirements, guidance, and examples of what Bayer considers a reportable event for the Essure® product. In section 5.1.10, Events not considered to be serious injury, Bayer references the May 2011 FDA letter as rationale why "dislocation or perforation without symptoms not requiring medical or surgical intervention (incl. micro-insert located in the abdominal cavity)" 177 events are not reportable. No updated or additional supporting clinical rationale is documented in this MDR Reporting Standard. 17 3 BAY-JCCP-0912068. 174 Id.. 175 BAY-JCCP-0912073. BAY-JCCP-0067237 at 54. 177 Ibid. 176 94 iii. Medical Device Reporting of Pregnancy Prior to May 28, 2004, FDA-OSB sent a letter to Conceptus seeking additional information related to voluntary MedWatch report MWl 031305 received by FDA-OSB February 19, 2004, 178 that reported uterine penoration(s). The FDA-OSB specifically asked Conceptus to describe reports they had received for pregnancy regardless of device failure. On May 28, 2004, Conceptus responded to the FDA-OSB request for additional information that Conceptus did not consider pregnancies to be MDR reportable. On August 10, 2004, Conceptus contacted FDA-OSB by phone and followed up with an e-mail providing FDA-OSB with the Conceptus communication of May 28, 2004, that included the justification for not reporting pregnancies as MDRs. On July 17, 2009, Conceptus issued a Regulatory Memo to file 179 stating that only ectopic pregnancies or pregnancies with complications were reportable. In the complaints we sampled, there were 33 reporting pregnancies with complications and 21 reporting ectopic pregnancies. Thirty-one (31) pregnancies with complications were not reported as MDRs, 18 of these after this memo was issued. Six (6) ectopic pregnancies were not reported as MDRs, three (3) after this memo was issued. On February 8, 2011, FDA-OSB sent a formal letter to Conceptus stating that they support pregnancy as not reportable as long as it is a natural state of occurrence noting specifically that ectopic pregnancies would be reportable. 18 Fourteen (14) pregnancies with complications were not reported as MDRs after this letter was received. Two (2) ectopic pregnancies were not reported as MDRs after this letter was received. ° C. FDA Inspections The FDA periodically inspects medical device manufacturers. Section 5.1.2 of the Investigations Operations Manual (IOM) 181 describes the inspection.al approach as "a careful, critical, official examination of a facility to determine its compliance with the laws and regulations administered by FDA." Section 5.2.3 of the IOM states the FDA 483, Inspectional Observations form is "intended for use in notifying the inspected establishment's top management in writing of significant objectionable conditions, relating to products and/or processes, or other violations of the FD&C Act and related Acts (see IOM 5.2.3.2) which were observed during the inspection. These observations are made when in the investigator's 'judgment' , conditions or practices observed, indicate that any food, drug, device, or cosmetic have been adulterated or are being 178 BAY-JCCP-1637076 9BAY-JCCP-0440014. 1so BAY-JCCP-0912068 181 INVESTIGATIONS OPERATIONS https://www.fda.gov/media/76769/download 17 MANUAL 2019, 95 Chapter 5, Establishment Inspections, FDA, prepared, packed, or held under conditions whereby they may become adulterated or rendered injurious to health." The following FDA inspectional observations gave Conceptus an opportunity to align their practices and procedures with FDA expectations and to clarify their understanding of FDA regulations. Conceptus missed these opportunities. • FDA Inspectional Observations (Form FDA-483): 182 o On February 24, 2005, FDA issued a Form FDA-483 to the foreign contract manufacturer, Venusa de Mexico, for Essure® devices. This 483 included two (2) observations related to complaint handling and MDR reporting. o Observation 2: Adequate quality requirements that must be met by suppliers and contractors were not defined and documented. Specifically, the firm has not assured that sufficient and adequate complaint / MDR procedures were maintained by Conceptus, Inc. regarding the Essure® System for Permanent Birth Control. This observation was annotated by the investigator as "Corrected and verified". This means the investigator was provided evidence that Venusa did assure Conceptus, Inc. maintained "sufficient and adequate complaint I MDR procedures." This evidence is unknown. o Observation 9: Records of complaint investigations do not include any corrective action taken. Specifically, • Complaints files number 0472. 0475, 0477, 0478, 0479, 0480, 0482; and 0487 referenced and/or stated that a Corrective Action had been initiated (CPAR 1066). The CPAR 1066 was not attached to the files. • In Complaint 487, CPAR 1066 is stated to be initiated to address Complaint 487 (IV1RRI282). Complaint 487 is not referenced or summarized in the CPAR. Observation 9 was annotated by the investigator as "Promised to correct". We reviewed 4,283 complaints whose aware date occurred after the issuance of this FDA-483. Of these, 368 had no corrective actions taken when there should have been. On January 6, 2011, the FDA issued a Form FDA-483 183 to Conceptus with observations that Conceptus did not report adverse event MDRs for three (3) perforations (Observation 1) and did not report malfunction MDRs for five (5) complaints (Observation 2). Conceptus agreed to submit an MOR for only one (I) of the eight (8) complaints specifically listed and continued to under-report the same or similar events. [See previous discussion under Section X Missed Opportunities, subsection B. FDA Communications on Perforations and Pregnancy] 182 183 BAY-JCCP-0050198. BAY-JCCP-0911996. 96 D. Internal Audits and Consultant Audits Reglera, a medical device consulting firm, performed a Mock FDA Inspection for Conceptus August 5-7, 2008. Reglera issued a Mock FDA Inspection Report184 to Conceptus on August 8, 2008. Mock FDA Inspections are an opportunity for companies to assess their compliance to FDA regulations prior to an FDA inspection or to check their corrective actions to FDA Inspection Observations to ensure actions taken were effective. The following table, Table 27, swnmarizes Reglera Mock FDA observations that were not adequately addressed as indicated by the results of our reviews of sampled complaints with aware dates after August 8, 2008. 184 DLSS0000042. 97 Table 27 Summary of 2008 Reglera Mock FDA Inspection Observations Reglera Finding Sampled Complaint Review Finding • All samples= 5182 (2002-2015) • Samples after Date of Reglera Report _{Aug\l~t_81 2008) = 2946 Finding Description # Good Documentation practices are not being appropriately followed in the completion of Quality Records. Numerous instances were noted during this audit in which checklists were notfiled out in their entirety. Also, changes were made to critical documents without a signature of the person making the change or the date on which the change occurred. Due to the frequency ofthese issues it appears that the lack ofproper GDS is a systemic issue. An appropriate corrective action would be the implementation of a GDP training program for all employees who are responsible for the completion ofquality records. 1 1 • • 4971 complaints in our sample set (95.9%) had deficient record content thus confinning this Reglera finding. Our sample set included 2907 complaints with aware dates after August 8, 2008 that had This finding included the following examples: deficient record content (2907 of 2946, 98.7%). An MDR event form, QAF-2729, associated with AR This confirms the manufacturer did not address 070251 was not filled out in its entirety. this Reglera finding in a manner that would AR 03042-Y79S contains several critical changes in the prevent its recurrence. Correction Action section of the Investigation Form. These corrections are not dated or initialed. This AR was initially deemed to not need a CAP A. Ultimately, through the changes to the AR, CAPA 08-006 was opened. The unique requirements imposed on Conceptus for MDR reporting may need explanation during an FDA audit. During 2 I this audit the written records of conversations with the FDA pertaining to these unique reporting requirements could not be found. It is advisable to maintain the complete records of any 98 Reference Section X. Missed Opportunities, subsection B. FDA Communications on Perforations and Pregnancy for a detailed discussion of this topic. Reglera Finding Sampled Complaint Review Finding • All samples= 5182 (2002-2015) • Samples after Date ofReglera Report (August 8, 2008} = 2946 Finding Description # discussion with the FDA related to MDR reportingfor future use, should an investigator have any questions about the content of the MDR Evaluation Forms. Without an adequate explanation of the specific reporting requirementsfor Conceptus an auditor may feel that events which traditionally require reporting were not. Such events include uterine verforations or pref;!nancies. The very large backlog of open complaints may be seen by the FDA as a violation of the requirements of 21 CFR part 820.198. Complaints are to be addressed in a timely fashion, according to the requirements of this section of the Quality 3 I System regulations. Some of the currently open complaints were originally opened in March, 2007. It seems likely that the complaint record would include even older open complaints if it were not for the fact that the current complaint handling system (CRM) was also activated in March 2007. Various discrepancies were noted in the handling and evaluation of the MDR Evaluation Fonns. 11zis also extended to the filing ofMedWatch forms. First, there appears to be considerable variability in the 4 I understanding of how the Vigilance Reporting Evaluation Our review agrees with this finding Our review agrees with this Reglera finding. Reference Section IX. Complaint and MDR Expertise, Training, and Qualifications for a more detailed discussion of our assessment related to the deficient qualifications and competencies of the personnel assigned complaint handling and MDR reporting responsibilities. Overall, 4128 of our sample set (79.7%) had some issue with the documented MDR assessment (incorrect decision, missmg decisions, missing reporting decision rationale, missing support for reporting rationale) confirming this Reglera finding. Form/MDR Evaluation Form is to be completed. ... This lack of consistency in the completion of this critical form may Our sample set included 2639 complaints inadvertently lead to lack ofadequate adverse event reporting. with aware dates after August 8, 2008 that had issues with the documented MDR assessment after the date of the Reglera Audit Report {89.6%). This confirms the manufacturer did not 99 Reglera Finding Sampled Complaint Review Finding • All samples= 5182 (2002-2015) • Samples after Date of Reglera Report (Augus_t_ 8, 2008) = 2946 Finding Description # address this Reglera finding in a manner that would prevent its recurrence. 4 Various discrepancies were noted in the handling and Two of these complaints were included evaluation of the MDR Evaluation Forms. This also extended to in our sample set. These are listed below with a the filing ofMed Watch forms. description of our findings: • AR01021-PPOPZX: Nature and details During this audit several events were noted in the of complaint were not sufficiently complaint files which appear to constitute probable reportable determined and documented; inadequate events. The following ARs and associated events will need to be rationale for no CAPA decision and for re-evaluated to determine if they require FDA notification: MDR reportability decision. We • AR-04400-CBXP. This AR records an event identified this complaint as having requiring the patient to be taken to a hospital for insufficient information to make an emergency intervention immediately following a MDR decision, therefore of Unknown procedure with a perforation. reportability. • AR 01021-PP09ZX The AR records a • AR03471-WYB5: MDR not filed. perforation event with the physician halting the Investigation documentation incomplete. procedure prior to completion. No additional We identified this as a complaint that information is available regarding the degree of should have been reported. the perforation and any follow up ofthe patients' There was.no indication either of these condition. complaints were re-evaluated as recommended • AR 03471-WYB5. This AR records chronic pain byReglera. associated with the device, requiring surgical intervention. This is a reportable event, except Additionally, 974 complaints in our that the physician states that he believes the sample set (18.8%) should have been reported condition is psychosomatic. No additionalfollow but were not after thus confirming this Reglera up is recorded and the final outcome is unknown. finding. 100 Reglera Finding # Finding Description • AR 070251. This AR indicates that a patient may have experienced hypervolemia following a procedure. No follow up is recorded. In all of the above noted cases the initial information made available to the complaint handler appears to indicate a significant event has occurred. Unfortunately, in each case insufficient data was included in the AR and investigation, or there was inadequate follow-up, to fully evaluate the significance ofthe event for reporting purposes. Sampled Complaint Review Finding • All samples= 5182 (2002-2015) · • Samples after Date of Reglera Report (August 81 2008) = 2946 Our sample set included 556 complaints with aware dates after August 8, 2008 that should have been reported but were not after the date of the Reglera Audit Report (18.9%). This confirms the manufacturer did not address this Reglera finding in a manner that would prevent its recurrence. Also, 2957 complaints in our sample set (57.1 %) had insufficient information included in the AR and investigation, or there was inadequate follow-up, to fully evaluate the significance of the event for reporting purposes and were identified as Unknown Reportability. This further confirms this Reglera finding. Our sample set included 1806 complaints with Unknown Reportability with aware dates after the date of the Reglera Audit Report (61.3%). This confirms the manufacturer did not address this Reglera finding in a manner that would prevent its recurrence. 4 Various discrepancies were noted in the handling and 109 complaints, out of 284 MDRs evaluation of the MDR Evaluation Forms. This also extended to submitted to the FDA in our sample set (38.4%), the filing ofMed Watch forms. were reported by the manufacturer after the required 30 calendar days from the aware date, thus confirming this Reglera finding. 101 Reglera Finding . Sampled Complaint Review Finding • All samples= 5182 (2002-2015) • Samples after Date ofReglera Report (~ugust 8, 1008) = ~946 Finding Description # The Essure® MDR log, covering only the period since February 2007 through the present, indicates that at least four MDR reports were filed with the FDA outside of the 30-day requirement. An additional two reports werefiled on the 30th day following notification and may likely receive additional scrutiny from an FDA auditor. Further investigation of the records associated with the above noted out-of-timeframe MDR reports indicated the following concerns: • AR 01818-5X9W This ectopic pregnancy occurred on 6/28/2007 and was reported to the FDA on 8/27/2007. The actual date Conceptus was notified is not clear in that the MDR log lists the date as 7/18/2007, while the MedWatch form lists 8/3/2007. The date listed in the MedWatch form was taken from the Event Description as no date is recorded in box G4 of this form. In addition, a statement was made in this form which indicated that additional information would be made available to the FDA at a later date. According to 21 CFR part 803.56 any additionalpertinent information gather by Conceptus should be given to the FDA within thirty days ofreceipt. No records indicate that this has happened. • AR 02847-BJSU. According to the MDR log this event was first brought to the attention of Conceptus on 12/11/2007 and was reported to the FDA on 2/28/2008. T1iis is obviously outside the reporting window. However, the "date received by manufacturer" on the MedWatch 102 Our sample set included 94 complaints with aware dates after August 8, 2008 that were reported to FDA by the manufacturer after the required 30 calendar days from the aware date (37.0% of the 254 MDRs in our sample set reported by the manufacturers after August 8, 2008). This confirms the manufacturer did not address this Reglera finding in a manner that would prevent its recurrence. Sampled Complaint Review Finding • All samples= 5182 (2002-2015) • Samples after Date of Reglera Report (August 81 2008) = 2946 Reglera Finding Finding Description # • • form is listed as 2/25/2008. Though unlikely, this misalignment of dates may be interpreted by an astute auditor as an intentional misrepresentation. AR070385. The MedWatch form associated with this reportable event states that the firm was made aware on 2/27/2007. 111e MedWatch form was not submitted until 4/2/2007. Again, box G4 was not completed on this form. AR-02635-E5UP. The MedWatch form associated with this event indicates that the form was filed 30 days following the reportable event. Unfortunately, the official records associated with this complaint could not be located during this audit. While there may be no deviations associated with this MDR or the complaint handling process, the lack of documentation could be problematic during an audit iffor no other reason than the requirement to maintain all records and make them available for review. Also, this MedWatch form contains a statement that additional information will be made available to the FDA at a later date. No records exist that any such information was presented. During our review of the sample set of During this audit a review of the CAPA system, focusing complaints, bent tip was a regularly reported 5 I on those CAPAs that are related to complaints, was undertaken. complaint throughout the sample set. This audit identified several significant concerns related to the 103 ---- Reglera Finding # Sampled Complaint Review Finding • • Finding Description documentation ofcorrective actions and the effectiveness ofthose actions. All samples= 5182 (2002-2015) Samples after Date of Reglera Report (August 8, 2008) =2946 For the period 2002-2015, our sample set included 731 complaints that mentioned bent tip as a product concern. CAPA 03-025. This CAPA relates to the prevalence ofthe bent tip failure mode for the Essure® device. Several concerns were noted during the review of this CAPA. The concerns may not rise to the level of a deviation which would appear on an FDA'-483, Notice of Observations, but will need to be addressed in future CAPAs to improve the CAPA system. The intent of and motivation for CAPA 03-025 was to counter the rise in total% failures due to the bent tip. According to the final CAPA report, short term corrections included education ofphysicians on the proper technique for implantation. Long term solutions included a reorientation ofthe tip in the catheter. According to the CAPA both the long and short term solutions were implemented successfully. Unfortunately no records were found that document any training for physicians. Records do exist which show the reoriented tip was put into production in November, 2003. The success of this CAPA was to be based on trended complaint data indicating a decline in the frequency ofthe bent tip failure mode. Trended data from the time of the CAPA generation show a bent tip failure rate of 1.02%. Current failure rates in this mode are approximately 1.26%, based on date gathered from a Q2 2008 Post Market Surveillance Analysis Report. This does not represent a reduction in the long term prevalence of this failure mode in this device. As such, the data does not appear to support the conclusion that the CAPA was succes§}j,,_l and should therefore be closed. 104 After August 8, 2008 - 2015, 387 complaints mentioned bent tip as a product concern. This confirms that the manufacturers did not take adequate action to prevent or minimize these occurrences and confirms the Reglera finding that CAPA 03-025 was not effective. Reglera Finding Sampled Complaint Review Finding • All samples= 5182 (2002-2015) • Samples after Date ofReglera Report (August 8, 2008} =- 2946 Finding Description # 4971 complaints in our sample set (95.9%) had deficient record content thus The complaint files are not organized in accordance with confirming this Reglera finding. the requirements of SOP-1630, Product Return, Complaint I Handling and Reporting. This SOP clearly identifies the required Our sample set included 2907 complaints 6 contents and documents for each complaint file. U,ifortunately, with aware dates after August 8, 2008 that had this audit revealed that the majority of the sampled complaint deficient record content (98.7%). This confirms files are either missing records or the records are incomplete. the manufacturer did not address this Reglera finding in a manner that would prevent its recurrence. There are numerous procedures which are required by regulation which are not currently in place at Conceptus. The needed procedures would codify practices already undertaken by Conceptus staff. The lack ofsuch high level procedures appears to have contributed to the large degree of variation in the Our review of manufacturers' performance of certain tasks undertaken by Conceptus procedures agrees with this finding. employees. 7 • • No WI or SOP exists which describes the process for initiating, completing or documenting the investigation of a complaint. This includes those investigations that are purely a paperwork review and the investigations conducted on returned product. No WI or high level SOPs exist which describe the use of the CRM system. Such a procedure is needed to standardize the use of the system by the various employees who have access to it. This includes describing the required content of the various data 105 Reference Section VIL Gap Analysis: A Review of Key Policies & Procedures showed non-conformances with FDA Regulatiions and Guidance for a discussion of the continuing gaps in the manufacturers' procedures that we identified during our review. Reglera Finding Sampled Complaint Review Finding • All samples=- 5182 (2002-2015) • Samples after Date ofReglera Report (August 81._2008) "" 2946 Finding Description # input areas and thorough explanations of the content ofpull down menus. • A thorough restructuring of· SOP 1 630 is recommended to reduce errors in content and make the SOP easier to use and understand. Current timeframes for the completion of the Vigilance Reporting Form are very short and may not be consistently met. This is currently difficult to determine due to the previously mentioned issues with this form. In addition, the SOP clearly identifies the responsible party for the completion of each step in the complaint handling procedure. However, through discussions with the various parties associated with the complaint handling process and affiliated systems it appears that the responsible party designations may not accurately reflect the groups or individuals actually performing those steps. An example is the identification of PS as the responsible group for the completion of the Vigilance Reporting Form. In actuality this form is completed by the medical liaisons in the clinical group. It may also be advisable to divide this SOP into sections designed to address the process of complaint handling and M DR reporting/or the various groups involved, such as PS, sales associates and medical liaisons. Training practices and records are deficient and do not The skills and competencies needed for a 8 I accurately or completely record who has been trained, when the person assigned responsibilities for complaint training occurred or who is in need ofadditional traininf.!. handling or MDR reporting were not in evidence 106 Reglera Finding # Sampled Complaint Review Finding • All samples= 5182 (2002-2015) • · Samples after Date of Reglera Report (August 81 2008) = 2946 Finding Description m the 5182 complaints reviewed as The Training records for a small sampling of Conceptus demonstrated by the results noted in Section IX. employees were reviewed as a component of this audit. The This is in agreement with this Reglera fmding. employees were selected based on their affiliation with the PS or complaint handling system. In addition, the Employee Training Reference Section IX. Complaint and SOP, SOP-00404, was reviewed and training records were MDR Expertise, Training, and Qualifications for evaluated to see if they met the requirement specified in that SOP. a more detailed discussion of our assessment In total approximately 10 employee trainingfiles were evaluated related to the deficient qualifications and for specific training. Training specifics included Vigilance competencies of the personnel assigned Report Training, CRM training and training in SOP-1630. complaint handling and MDR reporting Deviations noted including the following: responsibilities. • An electronic version ofthe training files for Jennifer West could not be located. Similarly, a search for a Note that training requirements and paper copy of this file found only an ·incomplete training records were not made available for our version. I review. • Laura Casas training file does not indicate that she has received training in the completion of the Vigilance Reporting Form. This is significant as she is identified on many of the completed Vigilance Reporting Fonns as the individual having completed it. • There is no record ofthe attendees of the initial CRM training class. This training took place at the time of the initial release ofthe CRM system in March, 2003. Any employees that have begun working at Conceptus since that time have not attended an equivalent training session. New employees have apparently received on-the-job traininf! in the operation of the 107 Sampled Complaint Review Finding • All samples= 5182 (2002-2015) • Samples after Date ofReglera Report (Auimst 8, 2008) = 2946 Reglera Finding Finding Description # • . CRM system although this training is not documented in employee files. There is no record of training in the investigation of complaints. Specifically, the three employees tasked with investigations of returned devices do not have any records of their training in this process. At the time of this investigation L P and P P had not been trained to the current version of the Complaint Handling Procedure, SOP 1630. 108 XI. CONCLUSIONS Based upon my review of the documents, including the complaint records sampled, as well as my knowledge and experience, it is my opinion that the manufacturer's complaint handling and reporting systems were inadequate and out-of-compliance with FDA regulations. 109 . 202?? Anne Hoiland Anne Holland CQA, CQE, CMQ/OE, RQAP-GLP, Exemplar Global Lead Auditor 7500 Rialto Blvd., Bldg. 1, Ste. 225 I Austin, TX 78735 I 512-328-9404 [ aholland@qaconsultinginc.com Summary 34 years of experience in Technical Leadership, Regulatory Compliance, Quality System Development, Consulting, Design Assurance, Auditing, and Regulatory Affairs in the medical device industry Started QA Consulting, Inc. and grew client base, consulting expertise and scaled the business from a local based company to a nationally known firm that holds certifications as an Historically Underutilized Business (HUB) and National Women's Business Enterprise Certification (WBENC). Core Competencies Quality System Regulations - Strategic Planning - Design controls - Customer Retention & Interaction - Good Laboratory Practices - Litigation Support - Quality System Remediation - Risk Management - Project & People Management Infusion Therapy System Regulations Professional Experience 2000 - Present CEO and Founder QA Consulting, Inc. Austin, TX 1993-1999 QA Systems Manager Sr. Manufacturing Engineer Sr. Quality Assurance Engineer Sulzer Carbomedics Austin, TX 1991-1993 Project Manager • Design Assurance Engineer Ohmeda Monitoring Louisville, CO 1987-1991 Quality Assurance Project Engineer Cobe BCT, Inc. Lakewood, CO 1986-1987 Quality Assurance Engineer Fischer Imaging Corporation 1985-1986 Project Engineer LA BAC Medical Systems Denver, CO Englewood, CO Career Highlights Consulting team obtained over thirty 510(1<) clearances primarily in orthopedic and cardiac spaces Created FDA registered contract services segment of QA Consulting based upon client need Participated in FDA audits, GLP audits, Notified Body Audits and FDA 483 remediation efforts in both corporate management and client representative capacities Conducted in excess of 100 Quality System audits to assess 21 CFR 820, ISO 13485, ISO 17025 and 21 CFR 58 compliance ranging from medical device manufacturers, laboratory facilities, machine shops, molders, and extruders to animal testing facilities Selected as outsourced QA Unit for preclinical animal study facility to ensure GLP compliance and implement Quality Management System improvements Developed and implemented complete 21 CFR 820, ISO 13485, ISO 14971, ISO 17025 and ISO 9001 compliant Quality Management systems for medical device suppliers and associated service providers. Systems inspected by FDA or Notified Bodies and proven sound Validated software systems that provide device traceability, labeling, and Part 11 compliance for support of regulatory submissions. The comprehensive approach prevented both user and efficiency problems while ensuring compliance with FDA, MDD, and HIBC Standards Researched and composed the nonclinical portion of a PMA for a Oass III implantable device. Developed 510(k)'s for additional implantable devices Adjunct faculty member for The National Graduate School's master's program in Quality System Management Selected by President of 0hmeda Monitoring as 'Key Player', top two percent (2%) of performers, which allowed participation in long-range strategic decisions Led Quality for a Canadian medical device facility in Calgary that included managing the QMS and implementation of cleanroom operations for a tissue valve product Developed and performed validation of complex systems such as: liquid chemical/ steam/ VHP/ filter sterilization processes, dye penetrant testers, cleaning and dehydrogenation, de-ionized water, laboratory and custom manufacturing instrumentation, tubing sets, and packaging systems Developed and validated an aseptic transfer process for a biological product. Conducted media fills demonstrating system effectiveness Volunteered as a Quality Texas Foundation Examiner to identify industry role models based upon Malcolm Baldridge criteria. Volunteered as a judge for the 2011 World Conference on Quality Improvement's Team Excellence Award Process Education and Certifications M.B.A., University of Colomdo, Denver, CO 1991 Dean's List, Beta Gamma Sigma Honorary Society B.S. in Biomedical Engineering, Vanderbilt University, Nashville, TN 1985 Dean's List American Society for Quality: Certified Quality Auditor, certification # 12060 Certified Quality Engineer, certification# 15634 Certified Manager of Quality/Organizational Excellence, certification # 02904 Exemplar Global: Quality Management System Lead Auditor, certification #104799 Society of Quality Assurance: Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP) 2011-present Representative Seminars and Continuing Education Certified Quality Engineer Course Instructor, Austin Community College, May 2003 Risk Management & Medical Devices, Noblitt & Rueland, February 2004 Quality System Requirements and Industry Practice Course, Association for the Advancement of Medical Instrumentation, November 2005 Quality Systems Educational Forum: Design Controls, FDA Medical Device Industry Coalition, April 2008 American Society for Quality, Supplier Quality, Process Control and Risk Course, October 6-7, 2008 Biomedical Engineering Society Annual Meeting, October 2010 Fifth Annual FDA Inspections Summit, FDA News, November 3-5, 2010 GLPs for Study Directions and Monitors, West Coast Quality Training Institute, April 19-21, 2011 Professional Development Webinar: Computer System Validation/Part 11, Society of Quality Assurance, July 26, 2011 Educational Forum on MDR Complaints, and Recalls, Corrections and Removals, FDA Medical Device Industry Coalition, June 15, 2012 Reprocessing Reusable Medical Devices-Cleaning & Labeling Requirements, Global Compliance Panel, October 23, 2012 Professional Development Webinar: Good Clinical Laboratory Practices Auditing, Society of Quality Assurance, October 26, 2012 RAPS Texas Chapter Meeting, Emerging Technologies in Medicine, January 16, 2014 MMA Roadshow: A Workshop Managing App Development under FDA Regulation, FDA CDRH, April 16, 2014 4th Global QA conference/30th SQA Annual Meeting, Society of Quality Assurance, April 6-8, 2014 2014 RAPS The Regulatory Convergence, Regulatory Affairs Professional Society, September 27-October 1, 2014 5th Annual Medical Device Global Regulatory Intelligence, Ql Productions, July 27-28, 2015 Austin Quality Conference, American Society for Quality, November 6, 2015 Trends in FDA Inspections, RAPS Texas Chapter Meeting, November 6, 2015 Quality System Survival: Success Strategies for Production and Process Control, and CAPA, FDA Medical Device Industry Coalition, April 15, 2016 RAPS Texas Chapter: MDSAP - One Audit, Multiple Market Access, June 22, 2017 RAPS Preparing for MDSAP Audit Success, Maxch 22, 2018 Axeon EU MDR Training Course, October 5 and 6, 2018 Publications and Presentations "Automated Extraction of Activity Features in Linear Envelopes of Locomotor Electromyographic Patterns", R. Shiavi, J. Bourne, A. Holland, IEEE Transactions of Biomedical Engineering, 33(6):594-600, June 1986. "Risk Management Methods for Medical Devices", Texas A&M University Department of Biomedical Engineering, 2001. "Implement ISO 13485:2003 Successfully", Webinar Paton Professionals, March 2007 "Introduction to Process Validation", Two Day Workshop, September 2007 "Design Verification and Validation", FDA Industry Coalition, April 2008 "Risk Management for Cardiac Valves", One Day Workshop, March 2009 "Supply Chain Risk Management" Presentation, April 2010 "Quality Assurance and Regulatory Affairs", Texas A&M Guest Lecturer, April 2013 and February 2014 "Biomedical Engineering and Process Validation", Texas A&M Guest Lecturer, February 2014 "Entrepreneurship", Biomedical Engineering Society, Texas A&M, February 2014 "Current Trends in FDA Inspections", Austin Quality Conference, RAPS Texas Chapter Event, November 2015 "Efficient Validation Strategies and VMPs", FDA Medical Device Industry Coalition Big Event, April 2016 "Medical Device Quality" Presentation, TMCx Accelerator Program, September 2016 "Applying Risk Management Concepts throughout Your QMS", ASQ Austin, May 2017 "Risk Based Approach for Medical Devices Quality Management" Article, Quality Magazine, October 2017 "Four Dangerous Myths about Quality that May Cost Lives" Article, Quality Magazine, April 2019 Expert Witness and Litigation Support Maslon, Edelman, Borman & Brand, L.L.P. (Confidential Client) Expert Report of Anne Wilson- June 01, 2005 Stem, Shapiro, Weissberg & Garin LLP (Confidential Case) Expert Report of Anne Wilson, MBA- December 2, 2013 Deposition of Anne Wilson- January 28, 2014- Boston, MA Gerson Lehrman Group, Inc. (Confidential Client) Litigation Support 2013-2015 Law Office of Grant Morris - Grant Morris Litigation Support 2014-2016 Wexler Wallace LLP (Confidential Case) Expert Report of Anne Wilson, MBA- August 24, 2015 Deposition of Anne Wilson - September 17, 2015- New York, NY Expert Report of Anne Holland Wilson, MBA- January 25, 2016 Expert Report of Anne Holland Wilson, MBA- January 30, 2016 Expert Report of Anne Holland Wilson, MBA- February 1, 2016 Deposition of Anne Wilson - March 22, 2016 - Houston, TX Tracey & Fox Law Finn Litigation Support April 2017 Shine Lawyers, Sydney, Australia (Confidential Case) Expert Report of Anne Holland, MBA- August 24, 2016 Expert Report of Anne Holland, MBA - May 16, 2017 Onsite expert witness testimony, August 10 and 14, 2017 Professional Societies Women in Bio, Vice Chair of Communications Committee, 2015 Society of Quality Assurance, since March 2011 Biomedical Engineering Society 2010-2011 Regulatory Affairs Professionals Society, since 2008 Association for the Advancement of Medical Instrumentation, since 2007 American Society for Quality, Chair of Austin Section 2004-2005 American Society for Quality, Senior Member, since 2004 American Society for Quality, Senior Member, Member since 1990 Awards and Recognition Recognition of Dedication and Effort Towards the First Oinical Implant of the Photofix Pericardia] Valve, CarboMedics, December 1994 Certificate of Appreciation, Current Trends in FDA Inspections, RAPS Texas Chapter, November 15, 2015 Appreciation Award, Exceeding Expectations in the Hunt Valley Product Transfer, Encore Statistical Outsourcing Services 154 Gibbs Street #202 Rockville, MD 20850 Phone: 301-325-3129 http://www.statisticaloutsourcingserviccs.c:1.1m A binary event is when there are only two possible outcomes for an event. For example, either present or absent of an MDR for a complaint. The statistical distribution used to determine the probability an outcome for an event, when there are only two possible outcomes is called the binomial distribution. The proportion is the percent of the events with one of the possible outcomes. The power of the sample size for a proportion is based on the half-width of the confidence interval for a proportion. The most conservative method is to assume the hypothesized proportion is unknown assuming a 50% proportion which gives the largest interval for the difference from the true proportion that can be detected. Three different sampling strategies will be presented, each with five (5) different half-widths. There are several formulas for a binomial confidence interval, but all ofthem rely on the assumption of a binomial distribution. In general, a binomial distribution applies when an experiment is repeated a fixed number oftimes, each trial of the experiment has two possible outcomes (success and failure), the probability of success is the same for each trial, and the trials are statistically independent. The Clopper-Pearson interval is a very common method for calculating binomial confidence intervals 1. For this report, sample sizes will be calculated assuming the 50% proportion, with confidence interval widths ranging from ±1 % to ±5%. Since the intention is to determine the rate of non-compliance in a population of over 45,000 complaints, a statistically rational sample will be taken to estimate the true non-compliance rate as follows: 1. A single random sample of the population 2. A single random sample of the population, proportional to the number of complaints in a year (Stratified random sample) 3. A random sample for each year, with 100% sampling in years with less than the required sample size. As with all statistical sampling plans, the goal is select a sample size that is commensurate with the risk. There is no standard level of confidence that fits all questions or problems. Based information provided to Statistical Outsourcing Services, the appropriate level of confidence is 95%. 1 Clopper, C.; Pearson, E. S. (1934). "The use of confidence or fiducial limits illustrated in the case of the binomial''. Biometrika. 26: 404-413. Using the Clopper-Pearson method for calculating the confidence interval around a proportion of 50%, Table lshows the different sample sizes. As the actual nonconformance rate is unknown, this the most conservative estimate at the given confidence level. ± Half-Width of Interval Confidence Level 95% 99% 10564 15310 ±2% 2606 ±3% ±4% 1138 638 4440 1940 1084 ±5% 392 660 ±1% Table 1 shows that for a sample of 392 complaint records, with a 50% non- conformance rate, the true nonconformance rate is between 45% and 55% with 95% confidence (5% chance that the true non-conformance rate is outside the interval}. The actual confidence width is based on the observed proportion in the sample. .J:!':~I:"')t ·_.-c.r,:;J~~rr ~r tr\ ::.;·1:T.c?~.- ·~::·~;:::z The statistical inference is based on the "population" that was sampled. The most desirable approach is to sample equally from each year (when possible), which would give less confidence about the actual non-conformance in a given year, but when aggregated over the 15 years, will give a better estimate of the overall noncompliance, while still giving sound estimates for each year. f I r 1 •u ',, J 1 Each year, sample 392 complaint records (±5% at 95% confidence), estimating the percent nonconforming. Calculate the actual confidence interval for the given year. In years, with less than 392 complaints, do 100% sampling. After sampling all years, aggregate the results for a single proportion. Based on the distribution of the complaints supplied, the total sample size should be approximately 5280 complaints, which gives a half-width of ±1.4% at 95% confidence. Based on a pre-sample of complaints, the distribution of complaints in each year relative to their bucket, does not allow for a meaningful statistical statement about the defect rate within a bucket. Furthermore, though the number of complaints in a given year varies, it does not impact the inference for that year, but does impact any inference that would be made across years (Non-Compliance over time). An increase or decrease in complaint rates year over year could be an artifact of complaint bucket distribution, so any inference should be made with caution. g'h.er:.:s r 1.,m,•. , rr l.''t.:11,,i.lt::11c~.1-crt1.!DIL 1 1 '. As mentioned previously, the determination of the confidence interval around a proportion for a given sample size assumes that each event (complaint) factors into the decision about compliance/non-compliance. In other words, when the denominator fs 392 in a given year, the Clopper-Pearson confidence interval can be applied. When a subgroup of the complaints in a given year is evaluated for a specific aspect (type of injury in the MDR reports) only a point estimate should be provided. The confidence interval half-width (±5%) is based on a total sample size of 392. lfless than 392 records are reviewed to make a claim, the confidence intervals would be wider than the expected estimate of ±5%. Furthermore, no confidence interval should be applied to data with more than two possible outcomes (i.e. type of injury where there are 5 different types of injury a complaint can be categorized). I 1 J• /I -1 1 l / ' 1 ' 1 I I l . ~ ~ · '. ,, 1 1 I I ,' As mentioned previously, the sample size determination assumed a proportion of 50% as this provides the widest interval based on the binomial formula. The actual confidence interval for a sample size of 392 will be smaller than ±5% as the proportion moves away from 50%. Table 2 gives the actual half-widths for the confidence interval using the Clopper-Pearson approach. Proportion +/- 20% 4.32% 30% 4.81% 40% 5.04% 50% 5.06% 60% 4.89% 70% 4.50% 80% 3.86% As mentioned previously, confidence intervals should not be applied to proportions with a sample size less than 392 (actual confidence interval is wider than the predetermined ±5%). Confidence intervals should not be used when the different proportions are calculated from the. sample size (i.e. bucketing responses), as the distribution is no longer a binomial, requiring a different calculation for the confidence interval. I , • r ·• Agresti, A and Coull, B. A. (1998). Approximate is better than "exact" for interval estimation of binomial proportions", The American Statistician, 52(2), 119-126. Berenson M.L. and Levine D.M. (1996) Basic Business Statistics, Prentice-Hall, Englewood Cliffs, New Jersey. Brown, L. D. Cai, T. T, and DasGupta, A. (2001). Interval estimation for a binomial proportion", Statistical Science, 16(2), 101-133. Fleiss, J. L., Levin, B. and Paik, M. C. (2003). Statistical Methods for Rates and Proportions, Third Edition, John Wiley & Sons, New York. Hahn, G. J. and Meeker, W. Q. (1991). Statistical Intervals: A Guide for Practitioners, John Wiley & Sons, New York . Principal Consultant & Founder Statistical Outsourcing Services October 1, 2019 Summary of Reportability Critieria for Sampling Plan Company Position Over Time Reportable Situation Non• Reportable Considerations Pregnancy 1s natural state of occurrence x- 2014 Pregnancy serious comphcatlons Pregnancy (prior to tubal patency confirmation, unprotected sexl X 2014. Reportable with reportable for pregnancies with senous complicat1ons {e.g. preterm la borl or patient conditions requiring rntervent1on Expert Review Position Applicable Tlmeframe Reportable NonReportable X X Repo rtable if serious complications Non-Reportable: normal pregnancy, normal delivery/baby X Non-reporta ble: At time, device effectiveness has not been confirmed IFU and patient instructed to use alternative birth contra! method 2004-2014: Non-Reportable 2014 to 2016 Reportable 2011 to 2016 X ~ -, Pregnancy (Ectopic) 2009 to 2016 X Reportable all possible Ectopic pregnancies Reportable• if no other plausible " alternative explanation is available (e.g. hrstory of tate abortions) 2014 to 2016 X Reportable· spontaneous albortion (e g. miscarriage) after 12 weeks This does not include induced abortion Not reportable unless causality reported by re porter 2014to 2016 X ,. Spontaneous abortion (after 12 weeks) X Spontaneous abortion (before 12 weeks) )( Spontaneous abortion (without gestational age) X Procedure performed to induce abortion 2014to 2016 Not specified Perforation (no symptoms, no intervention) X Considerations No adverse symptoms, no rntervention X X )( 2004 to 2016 X X Non-reportable. as long as no other complications are known (e g. perforation! and cause is unknown Reportable Treat as worst-case {reportable) since specific feta l age 1s not know FDA requirement Is to report unless information able to demonstrate not reportable Case-by-case consider if abortion procedure is bem11 done as "intervention" Non-Reportable. No reported adverse impact (asymptomatic) and no intervention Perforation (with symptoms and intervention) X 2009 to 2016 X Reportable: Intervention t o prevent SI Perforation (during insertion requiring surgical intervention) X 2015 to 2016 X Reportable: Intervention t o prevent SI Page 1 ofs Summary of Reportability Critieria for Sampling Plan Expert Review Position Company Position Over Time Situation Reportable NonReportable Perforation (intervention, not Company instrument) X - 2011 X Fluid deficit or longer procedure duration (no adverse consequence, no treatment) Fluid deficit or longer procedure duration (due to physician offlabel use or non-Essure perforation, treatment required) Fluid deficit or longer procedure duration (due to Essure perforation, treatment required) Pain or other symptoms (caused by Essure, requires device removall Pain or other symptoms (not caused by Essure, device removal occurs as convenience or patient request) Pain (led to device removal via hysterectomy) Bleeding, pain, cramps, hypervolemia, allergic reactions, endometrial inflammations and infections (no intervention) Hidrosalpinx more than 4 weeks after Essure insertion Hidrosalpinx more than 4 weeks after Essure insertion X Considerations Essure itself didn't cause perforation IFU specifies duration Applicable Tlmeframe Reportable 2009 to 2016 X 2009 to 2013 NonReportable Considerations Reportable; MDR reportability 1s not dependent upon causal relationship X Non-Reportable: If no adverse event or treatment Consult Potential Reportable as malfunctlon {TBDI 2009 to 2013 X Reportable· As described, triaatment was required Off label use does not make event non-reportable X 2009to 2013 X Reportable· involves intervention X 2009 to 2013 X 2009 to 2013 X 2014 to 2016 X 2014 to 2016 X X X X X No intervention Reportable involves intervention (device removal) Reportable· involves intervention (device remova l). Causal relationship not reportability criteria X ' X X without complications and/or requiring intervention with complications and/or requirmg mtervention Chronic Pain (resulting in permanent impairment and intervention) X Includes conditions indicate a longer-term impa1rent of a specific body function, but also a long-term restriction of act1Y1ties of daily like, if potentially associated with Essure Pelvic Infection (intervention required) )( Within 4 weeks after implant Allergic reactions (requiring device removal) X 2015 to 2016 K Case-by-case to consider if intervention performed (e.g medication, hospita lization, addittonal testing or treatment, etc.) Non-reportable: without complications and/or requiring intervention Reportable with complications and/ or requiring intervention 2015 to 2016 X 2015 to 2016 X 2014 to 2016 X Reportable: involves intervention 2014to 2016 X Reportable Involves intervention Reportable. involves permanent impairment and/or intervention Page 2 of 5 Summary of Reportability Critieria for Sampling Plan Company Position Over Time Situation Reportable NonReportable Considerations Expert Review Position Applicable Tlmeframe Reportable NonReportable Considerations Surgery is elecuve, not required to prevent permanent Imparement or damage as a Placement failure (leading to tubal ligation) x- 2004 FDA position result of Essure procedure X Modified 2015: Essure insertion failure due to tube spagm and physician converts to 2009 to 2016 X ~ Case-by-Case to consider if tubal ligation is an intervention to address Essure failure (dapends on specific complaint situaitIonl laparoscopic tubal li2ation/salpmRectomy Bent Tip {no adverse medical or X extenuating circumstances) Device disloation/migration X 2014to 2016 X Reportable· Symptomatic and intervention No symptoms, no Intervention 2014: applies to any location 2012 to 2016 X Reportable malfunct ion unless data Is provided that supports non-reportable decision Reportable if removed via lapa roscopy 2014 to 2016 X Reportable device has moved into abdomen area, potential for SI With symptoms, surgical X intervention )( (in abdmonial cavity) )( X Device removal (from the uterine cavity with no complications or X 2014 to 2016 X 2014 to 2016 X X X details on relatedness) V3 reworded: Inc1dental surgical removal of device without explicit or implicit details on occurred, Consult MDR malfunction list Reportable. if symptomatic and/ or required intervention (removal). Non-reportable: 1f asymptomatic and d idn't require intervention intervention) Surgical removal of device (without · Case-by-Case to consider to detemme if AE 2005 to 2016 opened to investigate Device dislocation/migration Device dislocation/migration (in abdmonial cavity) No rationale for non-reportability given. Memo identified CAPA Reportable: rnvolves intervention (device removal) without informatio n t o support nonreportable relatedness) Surgical removal of device (despite statement from the HCP that the reported adverse events are not caused by Essure and no improvement of adverse events after device removal) Laparoscopic procedure in order to fi nd a missing Essure Device breakage inside body Change In 2015 X During insertion procedure or in ·x situ Device breakage noticed during prepation of insertion 2014 to 2016 X X X Non-reportable; with sufficient information to d emonstrate not being done as an intervention 2015 to 2016 X Reportable , Involves Intervention to p revent 2014 to 2016 X Reportable: Potential for death/ SI 2014 to 2016 X Non-reportable· Page3 ofS Summary of Reportability Critieria for Sampling Plan Company Position Over Time Situation Reportable NonReportable e.g Sepsis withrn 4 weeks after insertion X X Adverse Event (without causal relationship to Essure) X Planned but not yet performed intervention )( X X .. Planned but not yet performed intervention Planned but not yet performed intervention Reportable X NonReportable X X X MedWatch without supporting information m the case narrative For example· myoma, endometriosis, ovarian cysts, hair Joss, weight gain, vitamin deficiency Would be reportable, however, since intervent10n not performed, makes it nonreportable Reportable· if performed intervention is related to the device and case contains evidence that interventron has been performed Not Reportable if both conditions aren't met Reportable•with reasonable information to conclude intervention will be performed Note: Specrf,c guidance on lnterventton contained in V3 document Non-reportable: without reasonable rnformation to consider surgery will be actually planned. Examples Consumer reports AE with Essure requesting information about removal Consumer states she will need surgery to remove Essure considerattlons Case-by-Case, Device removal is surgical intervention Verify if interventron bei ng done to prevent serious injury. Consult MOR malfunction list 2014 to 2016 X Reportable: Potential for death/SI 2014 to 2016 X Incomplete 1nformat1on does not allow reportable SI to be made non-reportable 2014 to 2016 X Causal relationsh ip not required. Need explicit Information to not report Only 2014 X Reportable, lnintialty report MOR with patient follow-up and supplemental report, if needed Only 2014 X Reportable: device failure requiring intervention 1s reportable 2015 to 2016 X Reportable; lmntially report MOR with patient follow-up and supplemental report, if needed X Case-by-Case. Determine reportabillty based on the nature of the complaint Was AE/malfunctiOn reported or alleged? Was consumer calling to inquire about information (only)? Consider Reportable If report of injury and stating will have device removed Serious inJury indicated on Medwatch tickbox SI (without supportinll narrative) Planned/intended intervention Applicable Tlmeframe Not specified Essure Device Removal Life-threatening Considerations Expert Review Position 2015 to 2016 X Page4 of 5 Summary of Reportability Critieria for Sampling Plan Company Position Over Time Situation Reportable NonReportable Hysterectomy )( Hysterectomy performed due to myoma X Considerations For example: hysterectomy performed without further information or Essure ruined catlent's life Incidental surgical removal of device (hysterectomy for reasons NOT Involving Essurel Expert Review Position Applicable Tlmeframe Reportable 2014 to 2016 X 2015 to 2016 NonReportable Considerations Following Essure procedure failure (hysterectomy is major su rgery} X Non-reportable: surgical procedure not pe rformed as a result of Essure device Hysterectormy performed to remove embedded Essure from uterine cavitv/cervix X Reportable 2015 to 2016 )( Reportable: St wrth inte rvei"ltion Hysterectomy or Salpingectomy X Modified in V3 (20151: Reportable even if no med.cal reason 1s provided 2015 to 2016 )( Following Essure procedure failure (hysterectomy is major su rgery) Page 5 of 5 Conceptus / Bayer Documents Reviewed as part of Gap Analysis Assessment Doc;ument Ref# Revision Ref Number A C D E F BAY-JCCP-0062875 BAY-ESSURE-0009848 - BAY-ESSURE-0009862 BAY-ESSURE-0009862 BAY-JCCP-0085106-BAY-JCCP-0085116 BAY-JCCP-0062888-BAY-JCCP-0062898 BAY-JCCP-0062899 BAY-JCCP-0062909-BAY-JCCP-0062920 BAY-JCCP-0062921 BAY-JCCP-0062933-BAY-JCCP-0062945 BAY-JCCP-0420430-BAY-JCCP-0420442 BAY-JCCP-0062959-BAY-JCCP-0062970 BAY-JCCP-0062971-BAY-JCCP-0062985 BAY-JCCP-0062986-BAY-JCCP-0062999 BAY-JCCP-0063000-BAY-JCCP-0063014 BAY-JCCP-0448852-BAY-JCCP-0448866 BAY-JCCP-0208840-BAY-JCCP-0208855 BAY-JCCP-0208865-BAY-JCCP-0208880 BAY-JCCP-1064506-BAY-JCCP-1064525 BAY-JCCP-0216249-BAY-JCCP-0216269 BAY-JCCP-0210778-BAY-JCCP-0210798 BAY-JCCP-0063216-BAY-JCCP-0063221 BAY-JCCP-0194281-BAY-JCCP-0194292 BAY-JCCP-0196680-BAY-JCCP-0196683 BAY-JCCP-0197669-BAY-JCCP-0197675 BAY-JCCP-0525278 BAY-JCCP-0063163 BAY-JCCP-0063168 BAY-JCCP-0063173 BAY-JCCP-0063179 BAY-JCCP-0063186 BAY-JCCP-0063193 BAY-JCCP-0063200 BAY-JCCP-0063208 BAY-JCCP-0564291 BAY-JCCP-0140200 BAY-JCCP-0140208 BAY-JCCP-0140216 BAY-JCCP-2272465 BAY-JCCP-0762497-BAY-JCCP-0762498 BAY-JCCP-0196684-BAY-JCC P-0196684 BAY-JCCP-0472364-BAY-JCCP-0472364 BAY-JCCP-0860785 G H J K Product Returns, Complaint Handling and Reporting SOP-1630 L M N p R s T u V w y AA AB AC AD AE A B C D E F G H J K L M N Essure Complaint Handling SOP-3351 Complaint Alert Policy (Instructions) SOP-3180 B D Complaint Handling SOP (some files translated into foreign language) SOP-3300 A International Distributor Complaint Reporting SOP-3304 A A Handling of Product Technical Complaints and Suspected Counterfeit Incidents Handling of Incident Reports Page 1 of 4 GSOP-115 BDP-SOP-017 2 3 4 5 3 4 5 6 7 BAY-JCCP-0180451 BAY-JCCP-0066215-BAY-JCCP-0066238 BAY-JCCP-0066239-BAY-JCCP-0066263 BAY-JCCP-0066264-BAY-JCCP-0066288 BAY-JCCP-0066289-BAY-JCCP-006632 3 BAY-JCCP-2471288 BAY-JCCP-2463900 BAY-JCCP-3806183 BAY-JCCP-0672612 BAY-JCCP-1541190 Conceptus / Bayer Documents Reviewed as part of Gap Analysis Assessment Document Ref# Medical Device Reporting within US (equivalent to US-SOP-015-BPD) US303REGSSOP0063 SOP-015-BPD Processing ofTechnical Complaints SOP-608 Use of Dev@com for Technical Complaints with IRMS SOP-609 Medical Communications Inquiry Management SOP-623 Technical Complaints Electronic Case File Contents Guidelines (IRMS/Dev@com) US303REGSATT000719 Case Triage US303REGSSOP 593 Handling of Product Technical Complaints, Counterfeit Incidents and Usability Issues in Global Pharmacovigilance BDP-SOP-082 Revision Ref Number 1 2 BAY-JCCP-0062807 BAY-JCCP-0062826 BAY-JCCP-0062815 BAY-JCCP-1368247 BAY-JCCP-0063256 BAY-JCCP-013795 7-BAY-J CCP-0137969 BAY-JCCP-0137970-BAY-JCCP-0137982 BAY-JCCP-0137983-BAY-JCCP-0137994 BAV-JCCP-0138198-BAY-JCCP-0138205 BAY-J CCP-0138206-BAY-JCCP-0138213 BAY-JCCP-0138214 BAY-JCCP-0138072-BAY-JCCP-0138078 BAY-JCCP-0066359 BAY-JCCP-0066373 BAY-JCCP-0066387 BAY-JCCP-0066402 BAY-JCCP-0137945-BAY-JCCP-0137946 3 4 5 1 2 3 1 2 3 4 1 2 3 4 1 2 3 4 5 6 4 A Complaint Processing MDR Processing Wl-3304 Wl-3306 C BAY-JCCP-0062832 BAY-JCCP-0067643-BAY-JCCP-0067659 D BAY-JCCP-0062668-BAY-JCCP-0062684 E F A B C D E F BAY-JCCP-0062685 BAY-JCCP-0062702 BAY-JCCP-0062859-BAY-JCCP-0062866 BAY-JCCP-0067721-BAY-JCCP-0067728 BAY-JCCP-0067729-BAY-JCCP-0067736 BAY-JCCP-0067737-BAY-JCCP-0067744 BAY-JCCP-0067745-BAY-JCCP-0067753 BAY-JCCP-0067754-BAY-JCCPs0067762 BAY-JCCP-0062763 BAY-JCCP-0063375-BAY-JCC P-0063387 BAY-JCCP-0063388-BAY-JCCP-0063400 BAY-JCCP-0063401-BAY-JCCP-0063413 BAY-JCCP-0063414-BAY-JCCP-0063427 G A Transfer of Action Requests into the Complaint Database Wl-3329 B C MasterControl Complaints Database User Instructions Wl-3340 A Product Surveillance Inspection Methods Wl-3366 Complaint Capturing Wl-3429 Product Surveillance Laboratory Work Flow Wl-3448 Page2of4 BAY-JCCP-0137947-BAY-JCCP-0137948 BAY-JCCP-0137949-BAY-JCCP-0137950 BAY-JCCP-0138079-BAY-JCCP-0138084 BAY-JCCP-0138085-BAY-JCCP-0138090 BAY-JCCP-0138091-BAY-JCCP-0138096 BAY-JCCP-2469808 A BAY-JCCP-0063470 B B A B C D E F G BAY-JCCP-0063474 BAY-JCCP-0085308 BAY-JCCP-0062779 BAY-JCCP-0062783 BAY-JCCP-0062787 BAY-JCCP-0062791 BAY-JCCP-0062795 BAY-JCCP-0062799 BAY-JCCP-0062803 Conceptus / Bayer Documents Reviewed as part of Gap Analysis Assessment Document Ref# MasterControl HTML Complaint Form User Instructions Wl-3485 Returned Device Investigation Process Wl-3488 Complaint Call Center Scripts Wl-3518 Processing Complaints from Essure Clinical Trials Wl-3543 Processing Essure PTC Requests Essure IRMS Work Instruction Wl-3600 Wl-3634 Re11islon Ref Number A BAY-JCCP-0063477 B C A E 0 BAY-JCCP-0063485 BAY-JCCP-0063493 BAY-JCCP-0063501 BAY-JCCP-0063577 BAY-JCCP-0188426 BAY-J CCP-0063661-BAY-JCCP-0063664 SAY-J CCP-0063665-BAY-JCCP-0063670 BAY-JCCP-0063671-BAY-JCCP-0063676 BAY-JCCP-0270744 BAY-JCCP-0063677 BAY-JCCP-0063797 BAY-JCCP-0063809 BAY-JCCP-0063828 BAY-JCCP-0063848 BAY-JCCP-0063867 BAY-JCCP-0063886 BAY-JCCP-0063905 BAY-JCCP-0063924 BAY-JCCP-0063943 BAY-JCCP-0063964 BAY-JCCP-0063985 BAY-JCCP-0064008 BAY-JCCP-0064032 BAY-JCCP-0064113 BAY-JCCP-0064128 BAY-JCCP-0064142 BAY-JCCP-0063307 BAY-JCCP-0063309 BAY-JCCP-0063312 BAY-JCCP-0063314 BAY-JCCP-0063318 BAY-JCCP-0063323 BAY-JCCP-0063328 BAY-JCCP-0063334 BAY-JCCP-0083029-BAY-JCCP-0083035 BAY-JCCP-0065479 BAY-JCCP-0063346 BAY-JCCP-0063349 BAY-JCCP-0066054-BAY-JCCP-0066055 BAY-JCCP-0066058-BAY-JCCP-0066065 BAY-JCCP-0063303 BAY-JCCP-0063306 BAY-JCCP-0052005-BAY-JCCP-0052007 A B C D A A B C D E F Processing Essure Cases in Dev@com Wl-3635 G H J K L M N u Essure Case Review (Triage) Wl-3640 Complaint File AR R3184 M DR Product Return Alert (for tracking) R3185 A C A B A A Event Investigation R3186 MOR Reporting R3188 Receiving Potential Complaint Complaint Data Entry Using CRM R3189 R3203 Evaluation Form RA-1001 Administrative Returns Form QAF-2377 Vigilance Reporting Evaluation Form QAF-2729 B C D E A B A A 1 2 A D C (EXAMPLE) D BAY-JCCP-0052016-BAY-JCCP-0052017 (EXAMPLE) Action Request Form QAF-2730 AR Checklist QAF-2731 Page 3 of 4 E A B C D E F BAY-JCCP-0065473 BAY-JCCP-0080114 BAY·JCCP-0066103 BAY-JCCP-0066127 BAY-JCCP-0085182 BAY-JCCP-0085183 BAY-JCCP-0065476 Conceptus / Bayer Documents Reviewed as part of Gap Analysis Assessment Docume!'lt Ref# Complaint (AR) Investigation Form QAF-2732 AR Signature Closure Form QAF-2973 Page 4 of 4 Revision Ref Number A B C D E F G H J K L A BAV-JCCP-0066089 BAY-JCCP-0066109 BAY-JCCP-0066137 BAY-JCCP-0066138 BAY-JCCP-0066139 BAY-JCCP-0079156 BAY-JCCP-0079157 BAY-JCCP-0079159 BAY-JCCP-0079161 BAY-JCCP-0079163 BAY-JCCP-0079166 BAY-JCCP-0065478 DECLARATION 1. I, Gabriel Egli, am a partner of the law firm of Shook, Hardy & Bacon L.L.P. and counsel for defendants Bayer Corporation, Bayer HealthCare LLC, Bayer HealthCare Pharmaceuticals, Inc., and Bayer Essure Inc. (collectively, "Bayer") in the Essure litigation, including the JCCP No. 4887 coordinated proceedings. The information set forth in this declaration is within my personal knowledge or has been prepared with the assistance and advice of other counsel for Bayer, and, on that ground, I am informed and believe it to be accurate. 2. This declaration is provided for purpose of the JCCP No. 4887 coordinated proceedings, and in follow up to the agreement reached by Elizabeth Curtin and Fidelma Fitzpatrick regarding Plaintiffs' Motion to Compel Complaint Files. Summary 3. For the complaint files that Bayer has agreed to produce in response to Plaintiffs' requests in RFP Sets 5, 8-11, 13-18, 20-26, 28-35, and 36, Bayer searched DataSafe, Master Control, and Argus (the Conceptus and Bayer systems of record) for complaint files as defined in 21 CPR 820.198. 4. Bayer is not conducting additional searches to supplement the complaint files produced from these systems of record. 5. For each of the complaint files that has been produced to Plaintiffs in response to RFP Sets 5, 8-11, 13-18, 20-26, and 28-35 as of the date of this declaration, Bayer has produced the complaint file.as maintained by the company in the ordinary course of business. 6. For the requested 509 Conceptus-era paper complaint files that Bayer has been unable to locate in DataSafe, Bayer is in the process of identifying and will produce available complaint file data from alternative sources, if available. 7. Bayer expects additional complaint file productions as described in detail below but complaint file productions are otherwise substantially complete. Adverse Event Complaint Files 8. For Conceptus-era complaints requested by Plaintiffs in RFP Set 9 and identified by AR number in RFP Sets 5, 8, 10, 11, 13-18, 20-26, 32, and 35 (collectively "Conceptus-era complaints"), Bayer has made reasonable efforts to locate and produce complaint file data as maintained in the systems of record, DataSafe (through 2010) and Master Control (20 L02013). 9. For requested Conceptus-era complaints that Bayer migrated to Argus (Bayer's system of record), Bayer has also made reasonable efforts to locate and produce complaint file data 1 as maintained in Argus for the Argus case numbers associated with the requested Conceptus-era complaints. 10. For Bayer-era complaints requested in RFP Set 9, the "similar cases" requested in RFP Set 28, the complaints identified by Argus number in RFP Sets 29-34, and the complaints associated with the Dev@com numbers identified in RFP Set 36 (collectively ..Bayer-era complaints), Bayer has made (for RFP Sets 9 and 28-34) or will make (for RFP Set 36) reasonable efforts to locate and produce complaint file data as maintained in the system of record, Argus. 11. For requested Bayer-era complaints that originated during the Conceptus-era and were migrated to Argus, Bayer has also made reasonable efforts to locate and produce complaint file data as maintained in the Conceptus-era systems of record (DataSafe and Master Control). 12. For each of the Conceptus- and Bayer-era complaints reported to the FDA, Bayer has also made reasonable efforts to locate and produce MDRs. 13. For clarity, Bayer notes that Plaintiffs have requested 62 complaints (57 Argus case numbers and 5 AR numbers) that have been removed from active databases ("aborted" in Master Control or "deleted" from Argus). a. For 60 of these complaints, Bayer has produced or will produce complaint files from associated complaints, as reflected in Attachment A. b. Bayer Phannacovigilance has determined that 2 of these complaints (as reflected in Attachment A) are non-cases (i.e., have no adverse event). Accordingly, no complaint files exist for production. 14. Bayer has substantially completed production of complaint files for complaints requested before RFP Set 36. As of this date, Bayer has produced more than 44,000 complaint files, constituting more than 260,000 documents and 2.4 million pages. 15. Bayer has yet to produce complaint files for less than 2% of the total unique complaints requested by Plaintiffs. Complaint files that Bayer has yet to produce as of the date of this declaration are as follows: a. Approximately 90 documents in Slovenian associated with 17 Bayer-era complaints. Bayer is attempting to locate an attorney with Slovenian language skills to undertake the necessary protected health information (PHI) redaction review. b. Approximately 58 Bayer-era complaint files associated with the Dev@com numbers identified in RFP Set 36. 1 c. As identified in Attachment B, 120 Bayer-era complaint files, 3 Conceptus-era complaint files and 19 MDRs identified during Bayer's quality control review of 1 The remaining approximately 5,300 Bayer-era complaint files associated with the Dev@com numbers identified in RFP Set 36 were the subject of prior RFP Sets. 2 complaint file productions. Bayer estimates that it will complete production ofthese documents by July 26. d. 509 Conceptus-era complaints for which Bayer has been unable to locate complaint files in the systems of record. For these 509 complaints, Bayer is in the process of identifying and wiU produce avaiiable complaint file data from alternative sources. PrC Complaint Files 16. Bayer has agreed to produce and is in the process of collecting and reviewing underlying materials (if any) from Dev@com for the Bayer-era PTC complaints identified by Dev@com case number in RFP Set 36. Bayer has also agreed to produce and is in the process of collecting and reviewing underlying materials (if any) from Dev@com for the Bayer-era PTC complaints associated with requested Bayer-era complaints. Bayer estimates that it will substantially complete production of these materials by July 26. I declare under penalty of perjury under the laws of the State of California that the foregoing is true and correct. Executed on July !.12019. Gabriel Egli I l ! I I 1 I i I! ! 1 • ~ . j i 3 ' ,.l ~ t I Reliance List (Complaint Handling and Reporting) Page 1 Depositions 5/25/2017 Keith Abrams [PMQ] deposition and exhibits 1/11/2018 Michael Reddick [PMQ] deposition and exhibits 2/7/2018 Michael Reddick [PMQ] deposition and exhibits 2/13/2018 Christina Dickson [PMQ] deposition and exhibits 3/20/2018 Christina Dickson [PMQ] deposition and exhibits 4/18/2018 Michael Reddick [PMQ] deposition and exhibits 10/10/2018 Christina Dickson [PMQ] deposition and exhibits 10/18/2018 Michael Reddick [PMQ] deposition and exhibits 10/19/2018 Terry Mank [PMQ] deposition and exhibits 11/30/2018 Jamie Brown [PMQ] deposition and exhibits 2/13/2019 Lisa Mancer [PMQ] deposition and exhibits 3/13/2019 Michael Reddick deposition and exhibits 3/14/2019 Michael Reddick deposition and exhibits 3/19/2019 Robert McCarthy deposition and exhibits 3/20/2019 Robert McCarthy deposition and exhibits 3/21/2019 Randy Trimble deposition and exhibits 3/21/2019 Robert McCarthy deposition and exhibits 4/9/2019 Edward Sinclair deposition and exhibits 4/9/2019 Michael Reddick deposition and exhibits 4/10/2019 Michael Reddick deposition and exhibits 4/10/2019 Michael Reddick [PMQ] deposition and exhibits 4/10/2019 Edward Sinclair deposition and exhibits 4/16/2019 Edward Sinclair deposition and exhibits 5/1/2019 Alicia Lowery deposition and exhibits 5/10/2019 Laura Casas Abrignani deposition and exhibits 5/21/2019 Robert Feyerhenn deposition and exhibits 5/22/2019 Ayesha Siddiq deposition and exhibits 5/23/2019 Ayesha Siddiq deposition and exhibits 5/31/2019 Gregory Lichtwardt deposition and exhibits Reliance List (Complaint Handling and Reporting) Page2 6/19/2019 Ayesha Siddiq deposition and exhibits 6/25/2019 Andrea Machlett deposition and exhibits 6/27/2019 Ilona-Maria Weltrowski deposition and exhibits 7/1/2019 Cibele Rudge deposition and exhibits 7/2/2019 Cibele Rudge deposition and exhibits 7/3/2019 Cibele Rudge deposition and exhibits 7/26/2019 Rachelle Acuna-Narvaez deposition and exhibits 8/13/2019 Roberto Chaves deposition and exhibits. 8/14/2019 Roberto Chaves deposition and exhibits 9/5/2019 Edio Zampaglione [PMQ] deposition and exhibits 9/6/2019 Steve Yost deposition and exhibits 9/14/2019 Lois (Pierce) Price deposition and exhibits 9/17/2019 Edward Yu deposition and exhibits 9/18/2019 Edward Yu deposition and exhibits 9/18/2019 Terry Mank deposition and exhibits 9/23/2019 Wesley Gerber deposition and exhibits 9/24/2019 Christina Dickson [PMQ] deposition and exhibits 9/27/2019 Michael Voss deposition and exhibits Corporate Documents Listed By Title Product Returns, Complaint Handling and Reporting, SOP-1630 Essure Complaint Handling, SOP-3351 Handling of Product Technical Complaints and Suspected Counterfeit Incidents, GSOP-115 Handling of Individual Case Safety Reports, BHC-RD-SOP-013 Processing of Technical Complaints, US03REGS-_SOP000608 Case Triage, US03REGS-_SOP000593 Complaint Processing, WI-03304 MDR Processing, WI-03306 Complaint Capturing, WI-03429 Returned Device Investigation Process, WI-03488 Processing Essure PTC Requests, WI-03600 Reliance List (Complaint Handling and Reporting) Page 3 Processing Essure Cases in Dev@com, WI-03635 Essure Case Review (Triage), WI-03640 Event Investigation, R3186 MDR Reporting, R3 l 88 Evaluation Fonn, RA-1001 Complaint Alert Policy (Instructions), SOP-3180 Complaint Handling SOP (some files translated into foreign language), SOP-3300 International Distributor Complaint Reporting, SOP-3304 Essure Post Market Surveillance Monitoring, SOP-3354 Handling of Incident Reports, BDP-SOP-017 Medical Device Reporting within US, US303REGS - SOP 0063 Manage Reportable Medical Device Event, RD-O1-0231 Use ofDev@com for Technical Complaints with IRMS, SOP-609 Manage Reportable Medical Device Event, Op Instruction 1034 Dev@com User Information Letter, Dev@com User Letter 37 Technical Complaints Electronic Case File Contents Guidelines (IRMS/Dev@com), US303REGS - ATT 000719 Handling of Product Technical Complaints, Counterfeit Incidents and Usability Issues in Global Pharmacovigilance, BDP-SOP-082 Transfer of Action Requests into the Complaint Database, WI-03329 Master Control Complaints Database User Instructions, WI-03340 Product Surveillance Inspection Methods, WI-03366 Product Surveillance Laboratory Work Flow, WI-03448 MasterControl HTML Complaint Form User Instructions, WI-03485 Statistical Monitoring of Complaint Metrics or Monitoring and Reporting of Complaint Metrics, WI03490 Complaint Call Center Scripts, WI-03518 Processing Complaints from Essure Clinical Trials, WI-03543 Essure IRMS Work Instruction, WI-03634 Complaint File AR, R3 l 84 MDR Product Return Alert (for tracking), R3185 Reliance List (Complaint Handling and Reporting) Page4 Receiving Potential Complaint, R3189 Complaint Data Entry Using CRM, R3203 Administrative Returns Form QAF-2377 Vigilance Reporting Evaluation Form, QAF-2729 Action Request Form, QAF-2730 AR Checklist, QAF-2731 Complaint (AR) Investigation Form, QAF-2732 AR Signature Closure Form, QAF-2973 Third Party Complaint Notification Form, FORM-3314 Corporate Documents Listed by Bates Number***: *** The following list may only reference the first page ofthe identified document; however, it is to include all sequential pages ofsuch document. BAY-ESSURE-0047446 BAY-JCCP-0440014 BAY-JCCP-0440014 BAY-ESSURE-005 5270 BAY-JCCP-0016140 BAY-JCCP-0067416 BAY-JCCP-0067237 BAY-JCCP-0000001 BAY-JCCP-0000019 BAY-JCCP-0321995 BAY-JCCP-0080114 BAY-JCCP-0066103 BAY-JCCP-0066127 BAY-JCCP-0085182 BAY-JCCP-0085183 BAY-JCCP-0066088 BAY-JCCP-0065476 BAY-JCCP-0079153 Reliance List (Complaint Handling and Reporting) Page 5 BAY-JCCP-0079154 BAY-JCCP-0079155 BAY-JCCP-0065476 BAY-JCCP-0066089 BAY-JCCP-0066109 BAY-JCCP-0066137 BAY-JCCP-0066138 BAY-JCCP-0066139 BAY-JCCP-0079156 BAY-JCCP-0079157 BAY-JCCP-0079159 BAY-JCCP-0079161 BAY-JCCP-0079163 BAY-JCCP-0079166 BAY-JCCP-0079166 BAY-JCCP-0063307 BAY-JCCP-0063309 BAY-JCCP-0063312 BAY-JCCP-0063314 BAY-JCCP-0063318 BAY-JCCP-0063323 BAY-JCCP-0063328 BAY-JCCP-0063334 BAY-JCCP-0083029-BAY-JCCP-0083035 BAY-JCCP-0065479 BAY-JCCP-0063340 BAY-JCCP-0063346 BAY-JCCP-0066054-BAY-JCCP-0066055 BAY-JCCP-0066058-BAY-JCCP-0066065 BAY-JCCP-1689358-BAY-JCCP-1689360 Reliance List (Complaint Handling and Reporting) Page 6 BAY-JCCP-0082561 BAY-JCCP-0768148 BAY-JCCP-0063287-BAY-JCCP-0063291 BAY-JCCP-0525274 BAY-JCCP-0383319 BAY-JCCP-0723824 BAY-JCCP-0514519 BAY-JCCP-1523201 BAY-JCCP-0383319 BAY-JCCP-1446972 BAY-JCCP-1253428 BAY-JCCP-0085593 BAY-JCCP-0188707 BAY-JCCP-0085605 BAY-JCCP-0550300 BAY-JCCP-1409056 BAY-JCCP-0063375-BAY-JCCP-0063387 BAY-JCCP-0063388-BAY-JCCP-0063400 BAY-JCCP-0063401-BAY-JCCP-0063413 BAY-JCCP-0085303 BAY-JCCP-0085308 BAY-JCCP-0154382 BAY-JCCP-0063477 BAY-JCCP-0063485 BAY-JCCP-0063493 BAY-JCCP-0063501 BAY-JCCP-0063521 BAY-JCCP-0063539 BAY-JCCP-0063557 BAY-JCCP-0063577 Reliance List (Complaint Handling and Reporting) Page 7 BAY-JCCP-00635 97 BAY-JCCP-0063600 BAY-JCCP-0063604 BAY-JCCP-0063608 BAY-JCCP-0063612 BAY-JCCP-0063616 BAY-JCCP-0063621 BAY-JCCP-0063626 BAY-JCCP-0063631 BAY-JCCP-0063635 BAY-JCCP-0063639 BAY-JCCP-0063643 BAY-JCCP-0063648 BAY-JCCP-0063652 BAY-JCCP-0063656 BAY-JCCP-0188426 BAY-JCCP-0085313 BAY-JCCP-0740695 BAY-JCCP-0063661-BAY-JCCP-0063664 BAY-JCCP-0063665-BAY-JCCP-0063670 BAY-JCCP-0063671-BAY-JCCP-0063676 BAY-JCCP-0085320 BAY-JCCP-0085324 BAY-JCCP-0085328 BAY-JCCP-0085332 BAY-JCCP-0270744 BAY-JCCP-0063677 BAY-JCCP-0063797 BAY-JCCP-0063809 BAY-JCCP-0063828 Reliance List (Complaint Handling and Reporting) Page 8 BAY-JCCP-0063848 BAY-JCCP-0063867 BAY-JCCP-0063886 BAY-JCCP-0063905 BAY-JCCP-0063924 BAY-JCCP-0063943 BAY-JCCP-0063964 BAY-JCCP-0063985 BAY-JCCP-0064008 BAY-JCCP-0064032 BAY-JCCP-0064056 BAY-JCCP-0064070 BAY-JCCP-0064084 BAY-JCCP-0064098 BAY-JCCP-0064113 BAY-JCCP-0064128 BAY-JCCP-0064135 BAY-JCCP-0064142 BAY-JCCP-0000019 BAY-JCCP-0138221 BAY-JCCP-0725646 BAY-JCCP-1154256 BAY-JCCP-7403173 BAY-JCCP-0009165 BAY-JCCP-0009255 BAY-JCCP-0009259 BAY-JCCP-0050198 BAY-JCCP-0523829 BAY-JCCP-0523832 BAY-JCCP-0523834 Reliance List (Complaint Handling and Reporting) Page9 BAY-ESSURE-0044602_ R BAY-ESSURE-0047976 R BAY-ESSURE-0059055 BAY-ESSURE-0065857 BAY-ESSURE-0095230 BAY-ESSURE-0095406_R BAY-JCCP-0135901 BAY-JCCP-0335954 BAY-JCCP-033605 l BAY-JCCP-0336268 BAY-JCCP-0336510 BAY-JCCP-0349541 BAY-JCCP-0349571 BAY-JCCP-0383310 BAY-JCCP-0498150 BAY-ESSURE-0045624-BAY-ESSURE-0045693 BAY-ESSURE-0045694-BAY-ESSURE-0045703 BAY-ESSURE-0048466_R-BAY-ESSURE-0048482_R BAY-ESSURE-0054215_R-BAY-ESSURE-0054232_R BAY-ESSURE-0062435-BAY-ESSURE-0062437 BAY-ESSURE-0062440-BAY-ESSURE-0062441 BAY-ESSURE-0064848-BAY-ESSURE-0064852 BAY-JCCP-0104611-BAY-JCCP-0104612 BAY-ESSURE-0064949-BAY-ESSURE-0064955 BAY-JCCP-0644988-BAY-JCCP-0644992 BAY-JCCP-0480257-BAY-JCCP-0480273 BAY-JCCP-0659819-BAY-JCCP-0659825 BAY-ESSURE-0047087-BAY-ESSURE-0047110 BAY-ESSURE-0047080-BAY-ESSURE-0047080 BAY-ESSURE-0048632-BAY-ESSURE-0048632 Reliance List (Complaint Handling and Reporting) Page 10 BAY-ESSURE-0029789-BAY-ES SURE-0029795 BAY-ESSURE-0042248-BAY-ESSURE-0042273 BAY-ESSURE-0028999_R-BAY-ESSURE-0029623_R BAY-ESSURE-0044602_R-BAY-ESSURE-0045037_R BAY-ESSURE-0045038_R-BAY-ESSURE-0045197_R BAY-ESSURE-0047976_R-BAY-ESSURE-0048169_R BAY-ESSURE-0053220_R-BAY-ESSURE-0053467_R BAY-ESSURE-0055424_R-BAY-ESSURE-0055700_R BAY-JCCP-0498150-BAY-JCCP-0498202 BAY-ESSURE-0059055-BAY-ESSURE-0059241 BAY-ESSURE-0065857-BAY-ESSURE-0066436 BAY-ES SURE-0095230-BAY-ESSURE-0095405 BAY-JCCP-0065614 BAY-ESSURE-0039654 R-BAY-ESSURE-0040296 R - - BAY-ESSURE-0033136_ R-BAY-ESSURE-0034031 _R BAY-ESSURE-0031607-BAY-ESSURE-003161 l BAY-ESSURE-0034216-BAY-ESSURE-0034221 BAY-JCCP-0067416 BAY-JCCP-0067237 BAY-JCCP-1254447 BAY-JCCP-0067279 BAY-JCCP-0065485 BAY-JCCP-0067192 BAY-JCCP-1580817 BAY-JCCP-3784615 BAY-JCCP-0065614 BAY-JCCP-0064208-BAY-JCCP-0064208 BAY-JCCP-0064209-BAY-JCCP-006421 l BAY-JCCP-0064212-BAY-JCCP-0064214 BAY-JCCP-0064215 Reliance List (Complaint Handling and Reporting) Page 11 BAY-JCCP-0064216 BAY-JCCP-0064228-BAY-JCCP-0064232 BAY-JCCP-0064217 BAY-JCCP-0064218-BAY-JCCP-0064220 BAY-JCCP-0064221-BAY-JCCP-0064223 BAY-JCCP-0064224 BAY-JCCP-0064225 BAY-JCCP-0064233-BAY-JCCP-0064237 BAY-JCCP-0051890-BAY-JCCP-0051895 BAY-JCCP-0051883 BAY-JCCP-0051899-BAY-JCCP-0051912 BAY-JCCP-0051913-BAY-JCCP-0051915 BAY-JCCP-0051916-BAY-JCCP-0051921 BAY-JCCP-0051922-BAY-JCCP-0051927 BAY-JCCP-0051949-BAY-JCCP-0051958 BAY-JCCP-0051959-BAY-JCCP-0051962 BAY-JCCP-0051963 BAY-JCCP-0051964-BAY-JCCP-0051965 BAY-JCCP-0051975 BAY-JCCP-0051976 BAY-JCCP-0051977 BAY-JCCP-0051978 BAY-JCCP-0051979 BAY-JCCP-0051968 BAY-JCCP-0051992-BAY-JCCP-0051993 BAY-JCCP-0051994-BAY-JCCP-0051995 BAY-JCCP-0051882 BAY-JCCP-0051996 BAY-JCCP-0052005-BAY-JCCP-0052007 BAY-JCCP-0052008-BAY-JCCP-0052010 Reliance List (Complaint Handling and Reporting) Page 12 BAY-JCCP-0052011-BAY-JCCP-0052013 BAY-JCCP-0052014-BAY-JCCP-0052015 BAY-JCCP-0052016-BAY-JCCP-0052017 BAY-JCCP-0052044-BAY-JCCP-0052063 BAY-JCCP-0052091 BAY-JCCP-0052092 BAY-JCCP-0052093 BAY-JCCP-0052095 BAY-JCCP-0052097 BAY-JCCP-0052098-BAY-JCCP-0052099 BAY-JCCP-0052100-BAY-JCCP-0052101 BAY-JCCP-0052102-BAY-JCCP-0052103 BAY-JCCP-0052104-BAY-JCCP-0052110 BAY-JCCP-0052111-BAY-JCCP-0052117 BAY-JCCP-0052118-BAY-JCCP-0052119 BAY-JCCP-0052120-BAY-JCCP-0052121 BAY-JCCP-O052122-BAY-JCCP-0052123 BAY-JCCP-0052124-BAY-JCCP-0052125 BAY-JCCP-0052126-BAY-JCCP-0052127 BAY-JCCP-0052128-BAY-JCCP-0052129 BAY-JCCP-0052130-BAY-JCCP-0052131 BAY-JCCP-0052132-BAY-JCCP-0052133 BAY-JCCP-0052134-BAY-JCCP-0052134 BAY-JCCP-0052135-BAY-JCCP-0052136 BAY-JCCP-0052137-BAY-JCCP-0052138 BAY-JCCP-0052139-BAY-JCCP-0052140 BAY-JCCP-0052141-BAY-JCCP-0052142 BAY-JCCP-0052143-BAY-JCCP-0052143 BAY-JCCP-0052144-BAY-JCCP-0052145 BAY-JCCP-0052146-BAY-JCCP-0052147 Reliance List (Complaint Handling and Reporting) Page 13 BAY-JCCP-0052148-BAY-JCCP-0052149 BAY-JCCP-0052150-BAY-JCCP-005215 l BAY-JCCP-0052152-BAY-JCCP-0052153 BAY-JCCP-0052154-BAY-JCCP-0052155 BAY-JCCP-0052156-BAY-JCCP-0052156 BAY-JCCP-0052157-BAY-JCCP-0052158 BAY-JCCP-0052159-BAY-JCCP-0052160 BAY-JCCP-0052161-BAY-JCCP-0052162 BAY-JCCP-0052163-BAY-JCCP-0052164 BAY-JCCP-0052165-BAY-JCCP-0052166 BAY-JCCP-0052167-BAY-JCCP-0052168 BAY-JCCP-0052169-BAY-JCCP-0052170 BAY-JCCP-0052171-BAY-JCCP-0052172 BAY-JCCP-0052173-BAY-JCCP-0052174 BAY-JCCP-0052176-BAY-JCCP-0052176 BAY-JCCP-0052190-BAY-JCCP-0052193 BAY-JCCP-0052194-BAY-JCCP-0052195 BAY-JCCP-0052196-BAY-JCCP-0052197 BAY-JCCP-0052198-BAY-JCCP-0052199 BAY-JCCP-0052200-BAY-JCCP-0052201 BAY-JCCP-0052202-BAY-JCCP-0052203 BAY-JCCP-0052204-BAY-JCCP-0052205 BAY-JCCP-0052206-BAY-JCCP-0052209 BAY-JCCP-0052210-BAY-JCCP-0052213 BAY-JCCP-0052214-BAY-JCCP-0052229 BAY-JCCP-0052230-BAY-JCCP-0052230 BAY-JCCP-0052231-BAY-JCCP-0052235 BAY-JCCP-0052236-BAY-JCCP-0052237 BAY-JCCP-0052238-BAY-JCCP-0052239 BAY-JCCP-0052240-BAY-JCCP-0052241 Reliance List (Complaint Handling and Reporting) Page 14 BAY-JCCP-0052242-BAY-JCCP-0052243 BAY-JCCP-0052244-BAY-JCCP-0052246 BAY-JCCP-0052247-BAY-JCCP-0052249 BAY-JCCP-0052250-BAY-JCCP-0052250 BAY-JCCP-0052251-BAY-JCCP-0052380 BAY-JCCP-0052381-BAY-JCCP-0052390 BAY-JCCP-0062664-BAY-JCCP-0062664 BAY-JCCP-0051997-BAY-JCCP-0051997 BAY-JCCP-0052018-BAY-JCCP-0052024 BAY-JCCP-0052175-BAY-JCCP-0052175 BAY-JCCP-0052177-BAY-JCCP-0052178 BAY-JCCP-0052393-BAY-JCCP-0052397 BAY-JCCP-0052401-BAY-JCCP-0052404 BAY-JCCP-0052405-BAY-JCCP-0052502 BAY-JCCP-0052503-BAY-JCCP-0052614 BAY-JCCP-0052615-BAY-JCCP-0052619 BAY-JCCP-0051884-BAY-JCCP-0051886 BAY-JCCP-0051887-BAY-JCCP-0051889 BAY-JCCP-0051896-BAY-JCCP-0051896 BAY-JCCP-0051897-BAY-JCCP-0051897 BAY-JCCP-0051898-BAY-JCCP-0051898 BAY-JCCP-0051928-BAY-JCCP-0051929 BAY-JCCP-0051930-BAY-JCCP-0051937 BAY-JCCP-0051938-BAY-JCCP-005 l 938 BAY-JCCP-0051939-BAY-JCCP-0051939 BAY-JCCP-0051940-BAY-JCCP-0051940 BAY-JCCP-0051941-BAY-JCCP-0051948 BAY-JCCP-0051966-BAY-JCCP-0051966 BAY-JCCP-0051967-BAY-JCCP-0051967 BAY-JCCP-0051969-BAY-JCCP-0051969 Reliance List (Complaint Handling and Reporting) Page 15 BAY-JCCP-0051970-BAY-JCCP-0051974 BAY-JCCP-0051980-BAY-JCCP-0051980 BAY-JCCP-0051981-BAY-JCCP-0051985 BAY-JCCP-0051986-BAY-JCCP-0051986 BAY-JCCP-0051987-BAY-JCCP-0051988 BAY-JCCP-0051989-BAY-JCCP-0051991 BAY-JCCP-0051998-BAY-JCCP-0051999 BAY-JCCP-0052000-BAY-JCCP-0052002 BAY-JCCP-0052003-BAY-JCCP-0052003 BAY-JCCP-0052004-BAY-JCCP-0052004 BAY-JCCP-0052025-BAY-JCCP-0052025 BAY-JCCP-0052026-BAY-JCCP-0052026 BAY-JCCP-0052027-BAY-JCCP-0052027 BAY-JCCP-0052028-BAY-JCCP-0052028 BAY-JCCP-0052029-BAY-JCCP-0052029 BAY-JCCP-0052030-BAY-JCCP-0052030 BAY-JCCP-0052031-BAY-JCCP-0052031 BAY-JCCP-0052032-BAY-JCCP-0052032 BAY-JCCP-0052033-BAY-JCCP-0052033 BAY-JCCP-0052034-BAY-JCCP-0052034 BAY-JCCP-0052035-BAY-JCCP-0052035 BAY-JCCP-0052036-BAY-JCCP-0052036 BAY-JCCP-0052037-BAY-JCCP-0052037 BAY-JCCP-0052038-BAY-JCCP-0052038 BAY-JCCP-0052039-BAY-JCCP-0052039 BAY-JCCP-0052040-BAY-JCCP-0052040 BAY-JCCP-0052041-BAY-JCCP-005204 l BAY-JCCP-0052042-BAY-JCCP-0052043 BAY-JCCP-0052179-BAY-JCCP-0052179 BAY-JCCP-0052180-BAY-JCCP-0052180 Reliance List (Complaint Handling and Reporting) Page 16 BAY-JCCP-0052181-BAY-JCCP-0052181 BAY-JCCP-0052182-BAY-JCCP-0052182 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Reporting) Page 17 BAY~JCCP-0053561-BAY-JCCP-0053567 BAY-JCCP-0053568-BAY-JCCP-0053575 BAY-JCCP-0053576-BAY-JCCP-0053582 BAY-JCCP-0053583-BAY-JCCP-0053590 BAY-JCCP-0053591-BAY-JCCP-0053598 BAY-JCCP-0053599-BAY-JCCP-0053606 BAY-JCCP-0053607-BAY-JCCP-0053614 BAY-JCCP-0053615-BAY-JCCP-0053622 BAY-JCCP-0053623-BAY-JCCP-0053630 BAY-JCCP-0053631-BAY-JCCP-0053638 BAY-JCCP-0053639-BAY-JCCP-0053646 BAY-JCCP-0053647-BAY-JCCP-0053654 BAY-JCCP-0053655-BAY-JCCP-0053661 BAY-JCCP-0053662-BAY-JCCP-005 3669 BAY-JCCP-0053670-BAY-JCCP-0053677 BAY-JCCP-0053678-BAY -JCCP-0053685 BAY -JCCP-0053686-BAY -JCCP-0053693 BAY-JCCP-0053694-BAY-JCCP-0053701 BAY-JCCP-0053702-BAY-JCCP-0053709 BAY-JCCP-0053710-BAY-JCCP-0053717 BAY-JCCP-0053718-BAY-JCCP-0053725 BAY-JCCP-0053726-BAY-JCCP-0053733 BAY-JCCP-0053734-BAY-JCCP-0053741 BAY-JCCP-0053742-BAY-JCCP-0053743 BAY-JCCP-0053744-BAY-JCCP-0053751 BAY-JCCP-0053752-BAY-JCCP-0053759 BAY-JCCP-0053760-BAY-JCCP-0053767 BAY-JCCP-0053768-BAY-JCCP-0053779 BAY-JCCP-0053780-BAY-JCCP-0053780 BAY-JCCP-0053781-BAY-JCCP-0053781 Reliance List {Complaint Handling and Reporting) Page 18 BAY-JCCP-0053782-BAY-JCCP-0053783 BAY-JCCP-0053784-BAY-JCCP-0053784 BAY-JCCP-0053785-BAY-JCCP-0053785 BAY-JCCP-0053786-BAY-JCCP-0053787 BAY-JCCP-0053788-BAY-JCCP-0053789 BAY-JCCP-0053790-BAY-JCCP-0053790 BAY-JCCP-0053791-BAY-JCCP-0053791 BAY-JCCP-0053792-BAY-JCCP-0053792 BAY-JCCP-0053793-BAY-JCCP-0053794 BAY-JCCP-0053795-BAY-JCCP-0053796 BAY-JCCP-0053797-BAY-JCCP-0053797 BAY-JCCP-0053798-BAY-JCCP-0053799 BAY-JCCP-0053800-BAY-JCCP-0053802 BAY-JCCP-0053803-BAY-JCCP-0053803 BAY-JCCP-0053804-BAY-JCCP-0053804 BAY-JCCP-0053805-BAY-JCCP-0053805 BAY-JCCP-0053806-BAY-JCCP-0053806 BAY-JCCP-0053807-BAY-JCCP-0053807 BAY-JCCP-0053808-BAY-JCCP-00538 l 7 BAY-JCCP-0053818-BAY-JCCP-0053820 BAY-JCCP-0053821-BAY-JCCP-0053826 BAY-JCCP-0053827-BAY-JCCP-0053831 BAY-JCCP-0053832-BAY-JCCP-0053835 BAY-JCCP-0053836-BAY-JCCP-0053848 BAY-JCCP-0053849-BAY-JCCP-0053856 BAY-JCCP-0062662-BAY-JCCP-0062662 BAY-JCCP-0062663-BAY-JCCP-0062663 BAY-JCCP-0062665-BAY-JCCP-0062665 BAY-JCCP-0062666-BAY-JCCP-0062666 BAY-JCCP-0052635-BAY-JCCP-0052638 Reliance List (Complaint Handling and Reporting) Page 19 BAY-JCCP-0052639-BAY-JCCP-0052640 BAY-JCCP-0052641-BAY-JCCP-0052777 BAY-JCCP-0052778-BAY-JCCP-0052873 BAY-JCCP-0052874-BAY-JCCP-0052874 BAY-JCCP-0052875-BAY-JCCP-0052927 BAY-JCCP-0052928-BAY-JCCP-0052983 BAY-JCCP-0052984-BAY-JCCP-0053089 BAY-JCCP-0053090-BAY-JCCP-0053128 BAY-JCCP-0053129-BAY-JCCP-0053246 BAY-JCCP-0053247-BAY-JCCP-0053300 BAY-JCCP-0053301-BAY-JCCP-0053381 BAY-JCCP-0053382-BAY-JCCP-0053428 BAY-JCCP-0053429-BAY-JCCP-0053506 BAY-JCCP-0053857-BAY-JCCP-0053892 BAY-JCCP-0051884-BAY-JCCP-0051886 BAY-JCCP-0051887-BAY-JCCP-005 l 889 BAY-JCCP-0051896-BAY-JCCP-0051896 BAY-JCCP-0051897-BAY-JCCP-0051897 BAY-JCCP-0051898-BAY-JCCP-0051898 BAY-JCCP-0051928--BAY-JCCP-0051929 BAY-JCCP-0051930-BAY-JCCP-0051937 BAY-JCCP-0051938-BAY-JCCP-005 l 938 BAY-JCCP-0051939-BAY-JCCP-0051939 BAY-JCCP-0051940-BAY-JCCP-0051940 BAY-JCCP-0051941-BAY-JCCP-0051948 BAY-JCCP-0051966-BAY-JCCP-0051966 BAY-JCCP-0051967-BAY-JCCP-0051967 BAY-JCCP-0051969-BAY-JCCP-0051969 BAY-JCCP-0051970-BAY-JCCP-0051974 BAY-JCCP-0051980-BAY-JCCP-0051980 Reliance List (Complaint Handling and Reporting) Page 20 BAY-JCCP-0051981-BAY-JCCP-0051985 BAY-JCCP-0051986-BAY-JCCP-0051986 BAY-JCCP-0051987-BAY-JCCP-005 l 988 BAY-JCCP-0051989-BAY-JCCP-0051991 BAY-JCCP-0051998-BAY-JCCP-0051999 BAY-JCCP-0052000-BAY-JCCP-0052002 BAY-JCCP-0052003-BAY-JCCP-0052003 BAY-JCCP-0052004-BAY-JCCP-0052004 BAY-JCCP-0052025-BAY-JCCP-0052025 BAY-JCCP-0052026-BAY-JCCP-0052026 BAY-JCCP-0052027-BAY-JCCP-0052027 BAY-JCCP-0052028-BAY-JCCP-0052028 BAY-JCCP-0052029-BAY-JCCP-0052029 BAY-JCCP-0052030-BAY-JCCP-0052030 BAY-JCCP-0052031-BAY-JCCP-0052031 BAY-JCCP-0052032-BAY-JCCP-0052032 BAY-JCCP-0052033-BAY-JCCP-0052033 BAY-JCCP-0052034-BAY-JCCP-0052034 BAY-JCCP-0052035-BAY-JCCP-0052035 BAY-JCCP-0052036-BAY-JCCP-0052036 BAY-JCCP-0052037-BAY-JCCP-0052037 BAY-JCCP-0052038-BAY-JCCP-0052038 BAY-JCCP-0052039-BAY-JCCP-0052039 BAY-JCCP-0052040-BAY-JCCP-0052040 BAY-JCCP-0052041-BAY-JCCP-0052041 BAY-JCCP-0052042-BAY-JCCP-0052043 BAY-JCCP-0052179-BAY-JCCP-0052179 BAY-JCCP-0052180-BAY-JCCP-0052180 BAY-JCCP-0052181-BAY-JCCP-0052181 BAY-JCCP-0052182-BAY-JCCP-0052182 Reliance List (Complaint Handling and Reporting) Page 21 BAY-JCCP-0052183-BAY-JCCP-0052184 BAY-JCCP-0052185-BAY-JCCP-0052185 BAY-JCCP-0052186-BAY-JCCP-0052187 BAY-JCCP-0052188-BAY-JCCP-0052189 BAY-JCCP-0052391-BAY-JCCP-0052392 BAY-JCCP-0052398-BAY-JCCP-0052398 BAY-JCCP-0052399-BAY -JCCP-0052400 BAY-JCCP-0052620-BAY -JCCP-0052621 BAY-JCCP-0052622-BAY-JCCP-0052624 BAY-JCCP-0052625-BAY-JCCP-0052626 BAY-JCCP-0052627-BAY -JCCP-0052629 BAY-JCCP-0052630-BAY-JCCP-0052630 BAY-JCCP-0052631-BAY-JCCP-0052631 BAY-JCCP-0052632-BAY-JCCP-0052632 BAY-JCCP-0053507-BAY-JCCP-0053507 BAY-JCCP-0053508-BAY-JCCP-0053508 BAY-JCCP-0053509-BAY-JCCP-0053509 BAY-JCCP-0053510-BAY-JCCP-0053511 BAY-JCCP-0053512-BAY-JCCP-0053513 BAY-JCCP-0053514-BAY-JCCP-0053521 BAY-JCCP-0053522-BAY-JCCP-0053523 BAY-JCCP-0053524-BAY-JCCP-0053524 BAY-JCCP-0053525-BAY-JCCP-0053526 BAY-JCCP-0053527-BAY-JCCP-0053528 BAY-JCCP-0053529-BAY-JCCP-0053536 BAY-JCCP-0053537-BAY-JCCP-0053543 BAY-JCCP-0053544-BAY-JCCP-0053551 BAY-JCCP-0053552-BAY-JCCP-0053560 BAY-JCCP-0053561-BAY-JCCP-0053567 BAY-JCCP-0053568-BAY-JCCP-0053575 Reliance List (Complaint Handling and Reporting) Page22 BAY-JCCP-0053576-BAY-JCCP-0053582 BAY-JCCP-0053583-BAY-JCCP-0053590 BAY-JCCP-0053591-BAY-JCCP-0053598 BAY-JCCP-0053599-BAY-JCCP-0053606 BAY-JCCP-0053607-BAY-JCCP-0053614 BAY-JCCP-0053615-BAY-JCCP-0053622 BAY-JCCP-0053623-BAY-JCCP-0053630 BAY-JCCP-0053.631-BAY-JCCP-0053638 BAY-JCCP-0053639-BAY-JCCP-0053646 BAY-JCCP-0053647-BAY-JCCP-0053654 BAY-JCCP-0053655-BAY-JCCP-0053661 BAY-JCCP-0053662-BAY-JCCP-0053669 BAY-JCCP-0053670-BAY-JCCP-0053677 BAY-JCCP-0053678-BAY-JCCP-0053685 BAY-JCCP-0053686-BAY-JCCP-0053693 BAY-JCCP-0053694-BAY-JCCP-0053701 BAY-JCCP-0053702-BAY-JCCP-0053709 BAY-JCCP-0053710-BAY-JCCP-0053717 BAY-JCCP-0053718-BAY-JCCP-0053725 BAY-JCCP-0053726-BAY-JCCP-0053733 BAY-JCCP-0053734-BAY-JCCP-0053741 BAY-JCCP-0053742-BAY-JCCP-0053743 BAY-JCCP-0053744-BAY-JCCP-0053751 BAY-JCCP-0053752-BAY-JCCP-0053759 BAY-JCCP-0053760-BAY-JCCP-0053767 BAY-JCCP-0053768-BAY-JCCP-0053779 BAY-JCCP-0053780-BAY-JCCP-0053 780 BAY-JCCP-0053781-BAY-JCCP-0053781 BAY-JCCP-0053782-BAY-JCCP-0053783 BAY-JCCP-0053784-BAY-JCCP-0053784 Reliance List (Complaint Handling and Reporting) Page 23 BAY-JCCP-0053785-BAY-JCCP-0053785 BAY-JCCP-0053786-BAY-JCCP-0053787 BAY-JCCP-0053788-BAY-JCCP-0053789 BAY-JCCP-0053790-BAY-JCCP-0053790 BAY-JCCP-0053791-BAY-JCCP-0053791 BAY-JCCP-0053792-BAY-JCCP-0053792 BAY-JCCP-0053793-BAY-JCCP-0053794 BAY-JCCP-0053795-BAY-JCCP-0053796 BAY-JCCP-0053797-BAY-JCCP-0053797 BAY-JCCP-0053798-BAY-JCCP-0053799 BAY-JCCP-0053800-BAY-JCCP-0053802 BAY-JCCP-0053803-BAY-JCCP-0053803 BAY-JCCP-0053804-BAY-JCCP-0053804 BAY-JCCP-0053805-BAY-JCCP-0053805 BAY-JCCP-0053806-BAY-JCCP-0053806 BAY-JCCP-0053807-BAY-JCCP-0053807 BAY-JCCP-0053808-BAY-JCCP-0053817 BAY-JCCP-0053818-BAY-JCCP-0053820 BAY-JCCP-0053821-BAY-JCCP-0053826 BAY-JCCP-0053827-BAY-JCCP-005383 l BAY-JCCP-0053832-BAY-JCCP-0053835 BAY-JCCP-0053836-BAY-JCCP-0053848 BAY-JCCP-0053849-BAY-JCCP-0053856 BAY-JCCP-0062662-BAY-JCCP-0062662 BAY-JCCP-0062663-BAY-JCCP-0062663 BAY-JCCP-0062665-BAY-JCCP-0062665 BAY-JCCP-0062666-BAY-JCCP-0062666 BAY-JCCP-0052633-BAY-JCCP-0052633 BAY-JCCP-0052634-BAY-JCCP-0052634 BAY-JCCP-0051882-BAY-JCCP-0051882 Reliance List (Complaint Handling and Reporting) Page24 BAY-JCCP-0051883-BAY-JCCP-0051883 BAY-JCCP-0051884-BAY-JCCP-0051886 BAY-JCCP-0051887-BAY-JCCP-0051889 BAY-JCCP-0051890-BAY-JCCP-0051895 BAY-JCCP-0051896-BAY-JCCP-0051896 BAY-JCCP-0051897-BAY-JCCP-0051897 BAY-JCCP-0051898-BAY-JCCP-0051898 BAY-JCCP-0051899-BAY-JCCP-0051912 BAY-JCCP-0051913-BAY-JCCP-0051915 BAY-JCCP-0051916-BAY-JCCP-0051921 BAY-JCCP-0051922-BAY-JCCP-0051927 BAY-JCCP-0051928-BAY-JCCP-0051929 BAY-JCCP-0051930-BAY-JCCP-0051937 BAY-JCCP~oos 1938-BAY-JCCP-0051938 BAY-JCCP-0051939-BAY-JCCP-0051939 BAY-JCCP-0051940-BAY-JCCP-0051940 BAY-JCCP-0051941-BAY-JCCP-0051948 BAY-JCCP-0051949-BAY-JCCP-0051958 BAY-JCCP-0051959-BAY-JCCP-0051962 BAY-JCCP-0051963-BAY-JCCP-0051963 BAY-JCCP-0051964-BAY-JCCP-0051965 BAY-JCCP-0051966-BAY-JCCP-0051966 BAY-JCCP-0051967-BAY-JCCP-0051967 BAY-JCCP-0051968-BAY-JCCP-0051968 BAY-JCCP-0051969-BAY-JCCP-0051969 BAY-JCCP-0051970-BAY-JCCP-005 l 974 BAY-JCCP-0051975-BAY-JCCP-0051975 BAY-JCCP-0051976-BAY-JCCP-0051976 BAY-JCCP-0051977-BAY-JCCP-0051977 BAY-JCCP-0051978-BAY-JCCP-0051978 Reliance List (Complaint Handling and Reporting) Page 25 BAY-JCCP-0051979-BAY-JCCP-0051979 BAY-JCCP-0051980-BAY-JCCP-0051980 BAY-JCCP-0051981-BAY-JCCP-0051985 BAY-JCCP-0051986-BAY-JCCP-0051986 BAY-JCCP-0051987-BAY-JCCP-0051988 BAY-JCCP-0051989-BAY-JCCP-0051991 BAY-JCCP-0051992-BAY-JCCP-0051993 BAY-JCCP-0051994-BAY-JCCP-0051995 BAY-JCCP-0051996-BAY-JCCP-0051996 BAY-JCCP-0051997-BAY-JCCP-0051997 BAY-JCCP-0051998-BAY-JCCP-0051999 BAY-JCCP-0052000-BAY-JCCP-0052002 BAY-JCCP-0052003-BAY-JCCP-0052003 BAY-JCCP-0052004-BAY-JCCP-0052004 BAY-JCCP-0052005-BAY-JCCP-0052007 BAY-JCCP-0052008-BAY-JCCP-0052010 BAY-JCCP-0052011-BAY-JCCP-0052013 BAY-JCCP-0052014-BAY-JCCP-0052015 BAY-JCCP-0052016-BAY-JCCP-0052017 BAY-JCCP-0052018-BAY-JCCP-0052024 BAY-JCCP-0052025-BAY-JCCP-0052025 BAY-JCCP-0052026-BAY-JCCP-0052026 BAY-JCCP-0052027-BAY-JCCP-0052027 BAY-JCCP-0052028-BAY-JCCP-0052028 BAY-JCCP-0052029-BAY-JCCP-0052029 BAY-JCCP-0052030-BAY-JCCP-0052030 BAY-JCCP-0052031-BAY-JCCP-0052031 BAY-JCCP-0052032-BAY-JCCP-0052032 BAY-JCCP-0052033-BAY-JCCP-0052033 BAY-JCCP-0052034-BAY-JCCP-0052034 Reliance List (Complaint Handling and Reporting) Page 26 BAY-JCCP-0052035-BAY-JCCP-0052035 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BAY-JCCP-0736674 BAY-JCCP-0736683 BAY-JCCP-0736809 BAY-JCCP-0740751 BAY-JCCP-0742002 BAY-JCCP-2435015 BAY-JCCP-2467353 BAY-JCCP-2467905 BAY-JCCP-0446506 BAY-JCCP-0721831 BAY-JCCP-0721956 Reliance List (Complaint Handling and Reporting) Page 56 BAY-JCCP-0722089 BAY-JCCP-2460211 BAY-JCCP-0270846 BAY-JCCP-0879920 BAY-JCCP-0902838 BAY-JCCP-1256689 BAY-JCCP-2466667 BAY-JCCP-0563333 BAY-JCCP-0721454 BAY-JCCP-0699913 BAY-JCCP-2474379 BAY-JCCP-0270871 BAY-JCCP-0563343 BAY-JCCP-0721400 BAY-JCCP-0563356 BAY-JCCP-0721442 BAY-JCCP-0270875 BAY-JCCP-0563368 BAY-JCCP-0563379 BAY-JCCP-0721389 BAY-JCCP-2270040 BAY-JCCP-2474366 BAY-JCCP-0563389 BAY-JCCP-0564227 BAY-JCCP-0743929 BAY-JCCP-0743940 BAY-JCCP-2266379 BAY-JCCP-2271928 BAY-JCCP-2271949 BAY-JCCP-2272571 Reliance List (Complaint Handling and Reporting) Page 57 BAY-JCCP-2273321 BAY-JCCP-0430660 BAY-JCCP-0743954 BAY-JCCP-0743964 BAY-JCCP-2274121 BAY-JCCP-2275834 BAY-JCCP-2275849 BAY-JCCP-2275864 BAY-JCCP-2275879 BAY-JCCP-0137699 BAY-JCCP-0137705 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BAY-JCCP-0623094-BAY-JCCP-0623097 BAY-JCCP-0679899 BAY-JCCP-0738143- BAY-JCCP-0738146 BAY-JCCP-0740680 BAY-JCCP-0740683 BAY-JCCP-0872722 BAY-JCCP-0875462-BAY-JCCP-0875465 BAY-JCCP-0953654-BAY-JCCP-0953657 BAY-JCCP-0738262- BAY-JCCP-073 8268 BAY-JCCP-0180451- BAY-JCCP-0180454 Reliance List (Complaint Handling and Reporting) Page 75 BAY-JCCP-0085184-BAY-JCCP-0085187 BAY-JCCP-2287758 BAY-JCCP-2466962 BAY-JCCP-0563842 BAY-JCCP-0671762 BAY-JCCP-2281674 BAY-JCCP-0699877 BAY-JCCP-0700349 BAY-JCCP-0544391 BAY-JCCP-0544446 BAY-JCCP-0700235 BAY-JCCP-0721613 BAY-JCCP-2281599 BAY-JCCP-2466804 BAY-JCCP-0719181 BAY-JCCP-0869858 BAY-JCCP-0872216 BAY-JCCP-2457483 BAY-JCCP-2462766 BAY-JCCP-0439678 BAY-JCCP-0740702 BAY-JCCP-0063163 BAY-JCCP-0063168 BAY-JCCP-0063173 BAY-JCCP-0063179 BAY-JCCP-0063186 BAY-JCCP-0063193 BAY-JCCP-0063200 BAY-JCCP-0063208 BAY-JCCP-0550293 Reliance List (Complaint Handling and Reporting) Page 76 BAY-JCCP-0744087 BAY-JCCP-2467334 BAY-JCCP-0279669 BAY-JCCP-0279673 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BAY-JCCP-0912073 BAY-JCCP-7048518 BAY-JCCP-7038334-BAY-JCCP-7038347 BAY-JCCP-024 7623-BAY-JCCP-0247629 BAY-JCCP-0138222-BAY-JCCP-0138230 BAY-JCCP-0912073-BAY-JCCP-0912074 BAY-JCCP-680 l466~BAY-JCCP-6801470 BAY-JCCP-2259196 BAY-JCCP-2277371 BAY-JCCP-0086358-BAY-JCCP-0066451 BAY-JCCP-0086091-BAY-JCCP-0086166 BAY-JCCP-0086902-BAY-JCCP-0086934 BAY-JCCP-0086992-BAY-JCCP-0087026 BAY-JCCP-008693 5-BAY-JCCP-0086961 BAY-JCCP-0086962-BAY-JCCP-0086991 BAY-JCCP-0086629-BAY-JCCP-0086663 BAY-JCCP-0086696-BAY-JCCP-0086737 BAY-JCCP-0086664-BAY-JCCP-0086695 BAY-JCCP-0086738-BAY-JCCP-0086766 BAY-JCCP-0086604-BAY-JCCP-0086628 BAY-JCCP-0086799-BAY-JCCP-0086836 BAY-JCCP-0086767-BAY-JCCP-0086798 BAY-JCCP-0086837-BAY-JCCP-0086872 BAY-JCCP-0086873-BAY-JCCP-0086901 BAY-JCCP-0086167-BAY-JCCP-0086173 BAY-JCCP-0086174-BAY-JCCP-0086 I 79 BAY-JCCP-0086598-BAY-JCCP-0086603 ABY-JCCP-0084124-BAY-JCCP-0084143 Reliance List (Complaint Handling and Reporting) Page94 BAY-JCCP-0084170-BAY-JCCP-0084186 BAY-JCCP-0084144-BAY-JCCP-0084160 BAY-JCCP-0084161-BAY-JCCP-0084169 BAY-JCCP-0066072-BAY-JCCP-0086090 BAY-JCCP-0084246-BAY-JCCP-0084263 BAY-JCCP-0084320-BAY-JCCP-0084341 BAY-JCCP-0084407-BAY-JCCP-0084428 BAY-JCCP-0084507-BAY-JCCP-0084526 BAY-JCCP-0084574-BAY-JCCP-0084586 BAY-JCCP-0084574-BAY-JCCP-0084586 BAY-JCCP-0084624-BAY-JCCP-0084642 BAY-JCCP-0084698-BAY-JCCP-0084714 BAY-JCCP-0084763-BAY-JCCP-0084777 BAY-JCCP-0084826-BAY-JCCP-0084843 BAY-JCCP-0084187-BAY-JCCP-0084211 BAY-JCCP-0084264-BAY-JCCP-0084281 BAY-JCCP-0084342-BAY-JCCP-0084363 BAY-JCCP-0084429-BAY-JCCP-0084452 BAY-JCCP-0084527-BAY-JCCP-0084545 BAY-JCCP-0084587-BAY-JCCP-0084598 BAY-JCCP-0084643-BAY-JCCP-0084660 BAY-JCCP-0084715-BAY-JCCP-0084730 BAY-JCCP-0084778-BAY-JCCP-0084793 BAY-JCCP-0084844-BAY-JCCP-0084861 BAY-JCCP-0084212-BAY-JCCP-0084229 BAY-JCCP-0084282-BAY-JCCP-0084300 BAY-JCCP-0084364-BAY-JCCP-0084387 BAY-JCCP-0084453-BAY-JCCP-0084477 BAY-JCCP-0084546-BAY-JCCP-0084557 BAY-JCCP-0084599-BAY-JCCP-0084609 Reliance List (Complaint Handling and Reporting) Page 95 BAY-JCCP-0084661-BAY-JCCP-0084678 BAY-JCCP-0084731-BAY-JCCP-0084746 BAY-JCCP-0084794-BAY-JCCP-0084809 BAY-JCCP-0084862-BAY-JCCP-0084878 BAY-JCCP-0084230-BAY-JCCP-0084245 BAY-JCCP-008430 l-BAY-JCCP-0084319 BAY-JCCP-0084388-BAY-JCCP-0084406 BAY-JCCP-0084478-BAY-JCCP-0084506 BAY-JCCP-0084558-BAY-JCCP-0084573 BAY-JCCP-0084610-BAY-JCCP-0084623 BAY-JCCP-0084679-BAY-JCCP-0084697 BAY-JCCP-0084747-BAY-JCCP-0084762 BAY-JCCP-0084810-BAY-JCCP-0084825 BAY-JCCP-0086180-BAY-JCCP-0086282 BAY-JCCP-0086283-BAY-JCCP-0086357 BAY-JCCP-0247623-BAY-JCCP-0247629 BAY-ESSURE-0009848-BAY-ESSURE-0009862 BAY-JCCP-1641466-BAY-JCCP-1641477 BAY-JCCP-0087027 BAY-JCCP-0087029 BAY-JCCP-0722678-0722681 BAY-JCCP-5457858-5457859 BAY-JCCP-0272182 BAY-JCCP-0008301 OOOlR Other Documents and/or Sources: Medical Device reporting for Manufacturers, Guidance for Industry and Food and Drug Administration Staff, U.S FDA, November 8, 2016 Medical Device Reporting for Manufacturers, Department of Health and Human Services, Food and Drug Administration, March 1997 https://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm 149236.htm Reliance List (Complaint Handling and Reporting) Page 96 Instructions for filling out the MedWatch 3500A FDA takes additional action to better understand safety of Essure, inform patients of potential risks, February 29, 2016 Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing postmarket review ofEssure and FDA's commitment to keep women informed Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight ofEssure device following discontinuation of its U.S. sales, December 20, 2018 Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency's continued commitment to postmarket review ofEssure and keeping women informed, July 20, 2018 Essure Permanent Birth Control: Reporting Problems to the FDA, December, 28, 2018 FDA Activities: Essure Bayer Announces Plan to Stop Selling and Distributing in the US (https://www.fdv.gov) Essure Permanent Birth Control Regulatory History (https://www.fdv.gov) FDA Meeting of the Obstetrics and Gynecology Devices Advisory Panel, September 24, 2015, Essure System for Permanent Sterilization (P020014) PowerPoint FDA's Review of Medical Device Reports Related to Essure Removal Between January 2017 to June 2018 Essure Permanent Birth Control System by Bayer Healthcare: Announcement-FDA Restricts the Sale and Distribution, April 9, 2018 All MDRs and Essure Reports received by the FDA, including those found on the MAUDE Database made available through a FOIA request Essure-SOPs from MasterControl-InfoCard Bayer PTC SOPs and Operating Instructions Essure Clinical Resource-Physician Training Manuals Essure Patient Information Booklets Essure Product Cases (JCCP No. 4887) Bayer Pharmacovigilance CAPAs (2015-Present) Essure Product Cases (JCCP No. 4887) Conceptus & BHC Milpitas Essure CAPAs (2002-2016) Essure System for Permanent Birth Control Executive Summary for the FDA Advisory Committee Meeting, September 24, 2015 Essure Obstetrics and Gynecology Devices FDA Advisory Committee Meeting, September 24, 2015 PowerPoint Summary of Safety and Effectiveness Essure System P020014 Reliance List (Complaint Handling and Reporting) Page 97 FDA Review Document Review of the Essure System for Hysteroscopic Sterilization Prepared for the September 24, 2015 meeting of the Obstetrics and Gynecology Devices Advisory Panel Center for Devices and Radiological Health (CDRH) United States Food and Drug Administration FDA PostMarket Questions to the Panel Panel Roster Obstetrics and Gynecology Devices Panel Essure® System for Permanent Birth Control, September 24, 2015 Brief Summary of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting- September 24, 2015 FDA Medical Devices Advisory Committee Obstetrics & Gynecology Devices Panel, September 24, 2015 Transcript Frederic S. Resnic, M.D. and Sharon-Lise T. Normand, Ph.D., Postmarketing Surveillance of Medical Devices-Filling in the Gaps, March 8, 2012. Essure-Conceptus & BHC Milpitas CAPA Log for 2002 to 2016 Any and all documents referenced within the Expert Report Federal Regulations: 21 CFR 820.198 21 CFR803