Exhibit A

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 1 of 16
-1- 

Comparison of Schedules 9 and 28 to Dr. Kessler’s 09.26.2016 Report 

Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

2/13/2004

REDACTED

513.a.

REDA

4/15/2004

REDACTED

176

REDA

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 2 of 16
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Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

4/21/2004 Bard’s April 21, 2004 Remedial Action Plan SPA 04-04- 02 stated that “Vena Cava Filter Adverse Event 

frequency rates will be reviewed on a quarterly basis. Rates will be obtained from: Maude, IMS, Lexis/Nexis and other medical literature as identified during the search. A comparison of the Recovery Vena Cava Filter to all other Vena Cava Filters will be completed. Frequency rates will be compared to assure that adverse events associated with the Recovery Filter are not occurring with excess frequency. Although this report will be an important element in deciding product status, the Division PAT realizes that comparative attempts to assess similar events via the above mentioned information sources do not yield reliable quantitative estimates for the following reasons: 1. Potential underreporting (Maude). 2. Potential over-reporter (IMS, sales data can only be roughly estimated). 3. Inadequate description of events in the Maude database, resulting in 

potential misclassification. 4. Very low frequency of 

events. 5. High variability in event rates and sales rates across devices and time periods.” 

499 n.80 Bard’s R002 policy defined a

also utilized a criterion wherother comparative filters. BaAction Plan SPA 04-04-02 sAdverse Event frequency ratquarterly basis. Rates will be IMS, Lexis/Nexis and other identified during the search. Recovery Vena Cava Filter twill be completed. Frequencassure that adverse events asFilter are not occurring with this report will be an importa

product status, the Division 

comparative attempts to asseabove mentioned information quantitative estimates for the Potential under-reporting (Mreporter (IMS, sales data can 3. Inadequate description of database, resulting in potentilow frequency of events. 5. and sales rates across device17-01-000153578) . . . 

4/23/2004 “I believe that the under-reporting of non-significant 

migrations will be so extreme that calculating a ‘proportion of migrations that are fatal’ based on MAUDE data will be entirely suspect. We should stick to the much more likely to be reported event of filter associated death, compared to estimated sales. This also has the best clinical relevance for practitioners.”

160 . . . I believe that the under-

migrations will be so extrem‘proportion of migrations thaMAUDE data will be entirelthe much more likely to be rassociated death, compared thas the best clinical relevanc

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 3 of 16
-3- 

Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

4/27/2004 In a Recovery Filter Migration HHE:

“These types of adverse events occur with all knowntypes of vena cava filters, and are extensively reported in the medical literature. Comparative attempts to assess similar events via the MAUDE database do not yield reliable quantitative estimates for a number of reasons: • Potential under-reporting • Inadequate description of events in the MAUDE database, resulting in potential misclassification • Very low frequency of observed events • Sales data can only be roughly estimated • High variability in event rates across devices and across time periods However, it is clear that since the MAUDE database has been kept, numerous instances of vena cava filters migrating to the heart with both fatal and nonfataloutcomes have been reported, as well as fatalities from the other known complications associated with the implantation of such devices.” 

166 Later in the Recovery Filter 

Lehmann stated: . . . These types of adverse eventof vena cava filters, and are medical literature. Comparatevents via the MAUDE dataquantitative estimates for a n• Potential under-reporting • Inadequate description of edatabase, resulting in potenti• Very low frequency of obs• Sales data can only be roug• High variability in event ratime periods However, it is clear that sincbeen kept, numerous instancmigrating to the heart with boutcomes have been reportedthe other known complicatioimplantation of such devices

4/21/2004 In the Bard Recovery Filter Migration Remedial Action 

Plan SPA-04-02, dated April 21, 2004, a tab titled “MAUDE Summary & Graphics,” included the following tables shown in the paragraphs: This chart, titled “Migrations per Units Sold” 

167-170 In the Bard Recovery Filter 

Plan SPA-04-02, dated April “MAUDE Summary & Grapshown in the paragraphs infrOne chart titled “Migrations following: 

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 4 of 16
-4- 

Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016A chart titled “Fatal Migratithe following: 

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 5 of 16
-5- 

Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016Another chart titled “Fatalitithe following: 

6/10/2004

REDACTED

209

REDA

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 6 of 16
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Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

7/15/2004 Janet Hudnall circulated via email a corporate approved 

document titled “Vena Cava Filter Complications – FAQs,” which included the following question and answer: “Q: Is Recovery® Filter a safe device? A: The Recovery filter was rigorously tested for all physical 

performance characteristics according to our established 

test methods and protocols and was found to meet all test specifications and requirements. As stated previously, Recovery® Filter’s overall complication rates are comparable to those reported in the literature and the MAUDE database for other filters.” 

513.b On July 15, 2004, Janet Hud

corporate approved documenComplications – FAQs,” whquestion and answer: “Q: Is device? A: The Recovery filall physical performance chaestablished test methods and meet all test specifications an

previously, Recovery® Filter

are comparable to those repoMAUDE database for other 00268921-923 at 923) 

11/17/2004

REDACTED

520

REDA

12/2004

REDACTED

180

REDA

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 7 of 16
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Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

12/9/2004

REDACTED

217

REDA

12/9/2004

REDACTED

219

REDA

12/17/2004 Dr. David Ciavarella provided another Health Hazard

Evaluation, with the subject line “Recovery Filter – Consultant’s Report,” on December 17, 2004, which noted, “Seventy-six reports of potentially serious hazards have been reported; 32 of those were judged to be serious, and 10 reports were associated with patient death....An analysis of reporting rates of serious adverse events for all inferior vena cava filters, as determined by analysis of the MAUDE and IMS databases by a consultant, revealed that reporting rates for Recovery are significantly higher than other filters. However, these databases are subject to known, significant biases that make calculation or comparison of incidence rates among 

products unreliable and inadvisable (according to experts 

and the FDA).” Dr. Ciavarella concluded that “[t]heFrequency category for serious injury (Critical Severity rating) is Occasional (32/20,827, or 0.153%).” 

221 Dr. David Ciavarella provid

Evaluation, with the subject Consultant’s Report,” on Denoted, “Seventy-six reports ohave been reported; 32 of thserious, and 10 reports were death....An analysis of reporevents for all inferior vena canalysis of the MAUDE and consultant, revealed that repsignificantly higher than othedatabases are subject to knowmake calculation or compari

products unreliable and inadv

and the FDA).” Dr. CiavareFrequency category for seriorating) is Occasional (32/20,01-01019773-825 at 821) 

12/17/2004 Dr. Ciavarella’s report further stated, “Reports of death, 

filter migration (movement), IVC perforation, and filter fracture associated with Recovery filter were seen in the MAUDE database at reporting rates that were 4.6, 4.4, 

222 Dr. Ciavarella’s report furth

filter migration (movement), fracture associated with RecoMAUDE database at reportin

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 8 of 16
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Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

4.1, and 5.3 higher, respectively, than reporting rates for all filters. These differences were all statistically significant.” 

4.1, and 5.3 higher, respectiall filters. These differences significant.” 

12/2004 In the December 2004 Health Hazard Evaluation, Dr. 

Ciavarella also noted the following: Is the Problem Expected & Within an Acceptable Statistical Range: From the analysis of the MAUDE and IMS databases, Recovery reporting rates are significantly higher than those of other filters. In conjunction with these data, there appears to be a significant correlation, although R2 values are only in the 0.5 range, of the migration reporting rates with the simulated migration resistance bench test. However, the flaws in the data collection methodologies makes calculation and comparison of actual incidence rates impossible from these data, and no definitive conclusions as to relative 

performance can be made. Adverse events rates reported 

in the literature are well above these reporting rates. But, as discussed above, direct comparisons of reporting rates to literature-derived rates are not possible because mostly 

permanent filters have been studied and the data have 

been collected using markedly different detection methods and patient populations. However, further investigation of these reported adverse events is warranted because of the size of the differences in the reporting rates and the correlation with the bench test of migration resistance.” 

223 In the December 2004 Healt

Ciavarella also noted the foll. . . “Is the Problem Expected & Statistical Range: From the IMS databases, Recovery rephigher than those of other filthese data, there appears to balthough R2values are only imigration reporting rates witresistance bench test. Howevcollection methodologies macomparison of actual incidenthese data, and no definitive 

performance can be made. A

in the literature are well abovas discussed above, direct coto literature-derived rates are 

permanent filters have been 

been collected using markedand patient populations. Howthese reported adverse eventsize of the differences in the correlation with the bench te. . 

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 9 of 16
-9- 

Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

1/4/2005

REDACTED

224

REDA

1/4/2005

REDACTED

226

REDA

1/4/2005

REDACTED

228

REDA

1/4/2005

REDACTED

228

REDA

2/16/2005

REDACTED

236

REDA

4/19/2005

REDACTED

237

REDA

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 10 of 16
-10- 

Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

7/16/2005 District Sales Manager Jason Greer emailed other Bard 

employees, including marketing executives Robert DeLeon and Janet Hudnall, regarding “Wesley’s situation...everyone’s situation,” and stated, “Cordis has brought forward the Maude database to her physicians and caused a problem.” Mr. Greer then suggested talking points during sales calls: “When you take out bariatric complications, our complications rates are lower than the other companies....[M]ay I suggest thesafest filter on the market that has been on the market for the longest time in its current form...The Simon Nitinol? If you want a filter that will give you the greatest chance of reducing your complications, The Simon Nitinol is that filter. (I have a spreadsheet from Maude that shows this).” 

242 On July 16, 2005, District S

emailed other Bard employeeexecutives Robert DeLeon an“Wesley’s situation...everyo“Cordis has brought forward 

physicians and caused a prob

suggested talking points duri

take out bariatric complicatioare lower than the other com

safest filter on the market tfor the longest time in its cuNitinol? If you want a filter greatest chance of reducing Simon Nitinol is that filter. Maude that shows this).” (BEmphasis added) 

7/18/2005 Janet Hudnall stated, “I handed out copies of the lists of 

accounts that were identified last Spring as ‘special needs’ accounts that could benefit from being included on the Roadshow....” The “Comments” column included the following statements: • “Heard of [Redacted] migration and won’t use” • “Recurrent PE resulting in death” • “Acc[ount] Has stopped using due to several reported complications” • “Stopped using; migration” • “Standard of care no longer Recovery; concerned about patient safety.” 

244 In the same email from July 

stated, “I handed out copies were identified last Spring as could benefit from being inc. . The “Comments” column statements: • “Heard of [Redacted] migr• “Recurrent PE resulting in • “Acc[ount] Has stopped uscomplications” • “Stopped using; migration• “Standard of care no longe

patient safety.” 

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 11 of 16
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Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

• “One of the first physicians to receive [Redacted] memo. Has not used it since.” • “Had filter fracture and seen several arms outside the caval wall.” • “Heard of [Redacted] migration and won’t use” • “Confirmation that everything is good” • “Failed removal due to tilted filter in young patient” • “Recurrent PE resulting in death” • “Stopped using, migration” • “MAUDE concerns” • “The standard of care for San Diego is no longer Recovery. He does not want to put himself or his 

practice at risk.” 

• “The entire group has stopped using Recovery. Thetrauma Drs. are concerned about the [Redacted] memo.” • “Fracture Concerns” 

• “One of the first physicianmemo. Has not used it since• “Had filter fracture and secaval wall.” • “Heard of [Redacted] migr• “Confirmation that everyth• “Failed removal due to tilt• “Recurrent PE resulting in • “Stopped using, migration• “MAUDE concerns” • “The standard of care for SRecovery. He does not want at risk.” • “The entire group has stoptrauma Drs. are concerned a• “Fracture Concerns” 

8/3/2005 REDACTED 246 REDA11/7/2005 After being forwarded Brian Hudson’s November 7, 

2005 email regarding “G2 Perforations,” Bard’s Head of Quality Assurance emailed Gin Schulz, BPV V.P., QA,et al., and stated, “Welcome to your first product challenge at BPV. It's obvious from the table below and the attached Maude summary that there are some major discrepancies regarding number of complaints, unitssold, rates etc. for G2. Your first cut at a Maude Analysis sends some signals for Caval Perforation and deployment that have to be investigated expeditiously. We need to assess the complete field assurance summary for AE's on G2 and not look at the individual failures 

389 After being forwarded Brian 

email regarding “G2 PerforaQuality Assurance emailed Get al., and stated, “Welcome challenge at BPV. It's obviothe attached Maude summary discrepancies regarding numrates etc. for G2. Your first sends some signals for Caval that have to be investigated eassess the complete field assuG2 and not look at the indivi

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 12 of 16
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Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

and try to rationalize them away as not being significantly different. In an effort to avoid any confusion regarding field performance on G2 and theconclusions made over the root cause of the reported AE's, I want you and your team to do the following:- Conduct a comprehensive complaint investigation including trend analysis for G2 with factual, verifiable data for number of events, sales data, and rates. - Compare your findings to pre-established DFMEA/Risk analysis criteria and determine if the trends are still within anticipated occurrence rates. Also determine if the severity of these events is consistent with your original assessment. - Establish complaint thresholds for these events for future trending so we can determine if we are approaching alert and action limits. - Present your failure investigation findings for these AE's along with your proposals for short and long term corrective action. - Determine if your trends are significant enough to warrant the creation of a remedial action plan per Corp RA policy R-002. 

rationalize them away as not In an effort to avoid any con

performance on G2 and the c

root cause of the reported AEteam to do the following: - Conduct a comprehensive cincluding trend analysis for Gdata for number of events, sa- Compare your findings to panalysis criteria and determinanticipated occurrence rates. severity of these events is coassessment. - Establish complaint threshofuture trending so we can deapproaching alert and action - Present your failure investiAE's along with your proposcorrective action. - Determine if your trends arwarrant the creation of a remRA policy R-002. 

11/30/2005 REDACTED 391 REDA8/1/2007 August 1, 2007 Report additionally stated, “Although 

most physicians believe that caudal migration has less serious patient safety implications than some other types of filter complications, they believe that a filter that moved caudally implies a general instability of the device 

414 The same August 1, 2007 Re

“Although most physicians bhas less serious patient safety other types of filter complicafilter that moved caudally im

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 13 of 16
-13- 

Date “Statement” from Schedule 28 Report 

Para. 

Kessler Report 09.26.2016

in situ and therefore felt less comfortable using it as their default filter....As well, a review of the MAUDE database was conducted, comparing the complaint rates of all commercially available filters against the SIR Guidelines.” 

the device in situ and therefoit as their default filter....As MAUDE database was conducomplaint rates of all commeagainst the SIR Guidelines” 783-784) 

12/31/2007 REDACTED 449 REDA2010 REDACTED 463 REDADate “Important Quotes” from Schedule 9 Report 

Para. 

Kessler Report 09.26.2016

3/10/2004

REDACTED

153

REDA

4/27/2004

REDACTED

165-166

REDA

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 14 of 16
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Date “Important Quotes” from Schedule 9 Report 

Para. 

Kessler Report 09.26.2016

6/30/2004 “Of the 6 events involving thrombi-encased filters that 

migrated to the heart, 4 were associated with patient death.” “The ‘malfunction’ is best understood as a limitation of the ability of the device to carry out its intendedfunction.” “The root cause of the migration event in these 10 cases is judged to be dislodgment of the filter due to the 

presence of a large thrombus. The exact mechanism of 

the dislodgment is unknown, but is presumed due to an acute increase in intracaval pressure (caudal to the filter) with resulting expansion of the IVC beyond the design limits of the filter.” “There have been 10 cases of migration reported for the Recovery filter, and about 10,000 filters have been

placed, giving a migration rate of approximately 0.1%.” . 

. . 

208 . . . An HHE by Dr. David 

2004 stated, “Of the 6 eventfilters that migrated to the he

patient death.” The HHE ind

migration involved whether tcomponent of a thromboemb‘malfunction’ is best understability of the device to carry Dr. Ciavarella further reportthe migration event in these dislodgment of the filter due thrombus. The exact mechan

unknown, but is presumed d

intracaval pressure (caudal to expansion of the IVC beyond filter.” He further reported tcases of migration reported fabout 10,000 filters have beerate of approximately 0.1%.00014836-839) 

7/9/2004 REDACTED 211 REDA11/17/2004 REDACTED 216 REDA12/17/2004 REDACTED 220-223 REDA

Case 2:15-md-02641-DGC Document 8231-1 Filed 10/18/17 Page 15 of 16
-15- 

Date “Important Quotes” from Schedule 9 Report 

Para. 

Kessler Report 09.26.2016

2/15/2006 REDACTED 396-407 REDA

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