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EXHIBIT 28 

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EXHIBIT 31 

Case 2:15-md-02641-DGC Document 8375-2 Filed 10/23/17 Page 18 of 120
03&0]]) 

PERIPHERAL 

VASCULAR 

Engineering Test Report Number 

ETR-04-03-02 

REVO 

Characterization of Recovery Filter Migration Resistance in 

Comparison to Competitive Product 

Phase 1 

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"----" - ----

~··· IIlLl..lilli.D Characterization of Recovery 

PEf:;:lPHEl~/>.L Filter Migration Resistance in ~ ETR-04-03-02 

VASCULAR Comparison to Competitive Rev. 0 

Product Phase 1 Page 2 of 13 

1.0 OBJECTIVE I PURPOSE OF TEST 

The objective of this study was to compare the Recovery Filter (RF) to competitive products in 

relationship to migration resistance. 

2.0 INTRODUCTION I BACKGROUND INFORMATION 

The design of the Recovery Filter was originally challenged for migration resistance 

capabilities by Nitinol Medical Technologies (NMT), the original design facility. The results of 

NMT's testing indicated that both the Simon Nltinol Filter and RF products were able to resist 

migration at the minimum pressure of 50 mmHg (predefined acceptance criteria) in 15 and 

28mm diameter mock vessels (ref. 3.3 and 3.4). 

Recent field activities indicate that migration failures have been reported for the RF product. 

Therefore, further testing of this specific characteristic is warranted. 

In conjunction with the field activities, a special Design Review was held on December 5th of 

2003 to gain a further understanding of the design elements of this product. In preparation for 

the special Design Review, the DFMEA for Recovery Filter was analyzed for critical elements 

to be discussed during the review (ref. 3.1 ). Migration resistance was one of the critical 

elements identified for review. The outcome from this special Design Review was a list of 

action items, many of which were related to migration resistance (ref. 3.2). 

One of the action items was to characterize the Recovery Filter migration resistance in 

comparison with competitive product (ref. 3.5). 

3.0 REFERENCE DOCUMENTS 

~~----~~----34----Memorandur n errtitled-''eesign-Revievv Objectivesior·Rec~FMR-iaunch-tproject ·~---­

#'s 7081 and 8008)", dated December 4th, 2003. 

3.2 Memorandum entitled "Special Design Review for Recovery (Project #'s 7081 and 

8008) Meeting Minutes", dated December 9th, 2003. 

3.3 RF Migration Study, Design Verification (RD-RPT-100) 

3.4 IVC Filter Migration Study (RD-SOP-035.02) 

4.0 TEST PROCEDURE -~--·-~··--·-· ---~--~~---------

Test protocol TPR-04-02-02 was followed with the deviations as noted in section 6.0. The 

phase 1 portion of testing is summarized in this report. The phase 1 testing included testing 

migration resistance of the following products: Bard Recovery Filter, Bard Simon Nitinol Filter, 

Boston Scientific Greenfield Stainless Steel, Boston Scientific Greenfield Titanium, B-Braun 

Ve11a Tectr,-eoold56ntherToJv,-eordis-'frapEase, arrd Cordis-OptE:ase. Tire filters wen~------~--·-···-·-·-·­

tested in the following simulated !VC diameters: 15mm, 18mm, 21mm, 25mm, 28mm, 30mm, 

and 32mm. 

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~- f.Billilll.D Characterization of Recovery 

PEi~lPHEl:(f\L Filter Migration Resistance in ~ ETR-04-03-02 

VASCULAR Comparison to Competitive Rev.O 

Product Phase 1 Page 3 of 13 

5.0 TEST MATERIALS 

5.1 Number of Samples: 

A minimum of 38 samples were evaluated as part of this study. 

5.2 Sample Size/Sample Grouping Rationale: 

The following samples sizes and groups were identified as test samples: 

··Qty~ ••••••·-•••Manufacturer 

I·····················•··························}··············· ···································>·········· ............... 10 C.R. Bard Recovery Filter 

10 C.R. Bard Simon Nitinol Filter 

3 Boston Scientific Greenfield (Titanium) 

3 Boston Scientific Greenfield (Stainless Steel) 

3 B-Braun Vena Tech LP 

3 Cook Gunther Tulip 

3 Cordis OptEase 

3 Cordis TrapEase 

10 NMT Recovery Filter (Tested only in 28mm tubing) 

It became necessary to replace filters when struts and major deformation occurred. 

-New.samp!es..were..gJven-IDsjnsubsequenLo~n..sorne .cases,-tbe-Samp!asize:~~~~ 

increased. 

5.3 Sample Identification: 

Samples were labeled following removal from packaging with the following 

1dent1f1cat1on numbers: 

.. $CI.OOPif11P #•······ > l(i(# •.... l\llaliyf~¢~lii"E}l' · . • •···· •·· •·•·••• • P~Mtii:>ti()li ... , ....................... 

RF1-RF21, RF32-RF34 07KN2852 C.R. Bard Recovery Filter 

SF1-SF10 07JN2673 C.R. Bard Simon Nitinol Filter 

GT1-GT3 6113410 Boston Scientific Greenfield (Titanium) 

GS1-GS3 6115450 Boston Scientific Greenfield (Stainless Steel) - ---- . -- ---

GS101-GS103 6201719 Boston Scientific Greenfield (Stainless Steel) 

VT1-VT3, VT101, VT102 F0507080 B-Braun Vena Tech LP 

TP1-TP3 1309079 Cook Gunther Tulip 

TP4, TP103 1304623 Cook Gunther Tulip 

~~-----~----~ -~---~---~~----- --- .. - . Qj -.Q3r_QjQ3__ RC1Rm\"\Q? .Cordis.. -~ Optease 

0102 R0903186 Cordis Opt ease 

T1-T3 R1103502 Cordis Trapease 

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PEi~l PHEFU\L Filter Migration Resistance in ~ ETR-04-03-02 

VASCULAR Comparison to Competitive Rev. 0 

Product Phase 1 Page 4 of 13 

NMT1-NMT10 Unknown I NMT Recovery Filter 

6.0 DEVIATIONS/EXCEPTIONS TO TEST PROTOCOL 

The initial testing was run on the test fixture and data sheet as specified in TPR-04-02-02. 

The testing on this initial fixture was more difficult due to the following: 

• The simulated sausage casing clots were getting caught on the rough transitions in the 1" 

PVC piping. 

• The temperature was being captured manually using a digital thermometer which took 

additional time. 

• The transducer display readings were in psi units instead of mmHg. 

All data sheets containing data recorded in psi units utilized the initial fixture. 

To expedite testing, the data sheet was revised and two new fixtures were manufactured. The 

following enhancements were made: 

• The new fixtures utilized %" PVC piping and the piping was reamed to smooth transitions. 

• Calibrated transducers with display readings in mmHg were utilized. 

• A thermocouple and temperature display was added to reduce testing time. 

All data sheets containing data recorded in mmHg units utilized the new fixtures. A 

___ ·----·---~ . photograph of the new fix!~§.i§.JC:>_(:~§Itecj_ in appendix 1. -----~·---

Initial testing utilizing 28mm diameter simulated IVCs was performed at 3rC ± 2°C per 

protocol; however, the temperature was changed thereafter to 40°C ± 3°C to follow suit with 

NMT protocol RD-SOP-035.02. The testing in the 28mm diameter simulated IVC was 

repeated at this new temperature. All subsequent simulated IVC diameters were tested at 

------AEP-6 l-32 6-in-the-felle>wing-erder 15mm~-ta-mm;-36mrft;-and-32mm.--~H~--­

important to note that the filters were all fatigued in this order. As samples broke (i.e. struts), 

they were replaced with new product. 

7.0 TEST RESULTS/SUMMARY OF DATA 

The data for the three runs of each filter was averaged before the summary statistics were 

~~~~calculate.d~----------· 

SF1-SF10 

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'J'~ti!l9 · i\ibe 

Temp; •·• t:>tal'l'leter 

("¢} • •·• [rrn'l\) 

40 ± 3 15 

Maximum 

(mwHsL 

0.25 154.3 155.1 

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PEi~! PHEFU\L Filter Migration Resistance in ETR-04-03-02 a....t VASCULAR Comparison to Competitive Rev.O 

Product Phase 1 Page 5 of 13 

.·•··· <(.••················ 

·:::.··:· .: ... ::::: .•.• filf~l' I /••••••· ·.:::::::::::::::::::: 

.,.~~t@i "tl.l~~ sHinc:lartl . . •:.:::• ·····:; :: / sampiEf ... .. -.' .... ' ... •.•:_•_•.•c.oc.·.······ Minimum· Maximum Telllf>· •.• Diameter Size 1:···.· ,f2':iL, ·Deviation [rnfl1flg).-••.••••. .. _ •• (J'l1fl11-!.9f .y · ... >• •<{~C):··•· (rJ!ijl) (nF · I Y''~)'P~J • ~Mni~~J ································ GT1-GT3 40 ± 3 15 3 155.1 0.00 155.1 155.1 

GS1-GS3 40 ± 3 15 3 143.8 18.88 122.0 155.1 

VT1-VT3 40 ± 3 15 3 155.1 0.00 155.1 155.1 

TP1-TP3 40 ± 3 15 3 137.0 6.80 130.3 143.9 

01-03 40 ± 3 15 3 154.4 0.98 153.3 155.0 

T1-T3 40 ± 3 15 3 155.0 0.00 155.0 155.0 

RF11-RF20 40 ± 3 18 10 .. ">7 '2 I.~I.V 9.95 111.0 143.9 

SF1-SF10 40 ± 3 18 10 152.9 4.00 142.9 155.0 

GT1-GT3 40 ± 3 18 3 153.3 1.93 151.2 155.0 

GS1-GS3 40 ± 3 18 3 142.0 10.78 129.6 148.8 

VT1-VT3 40 ± 3 18 3 121.0 12.34 107.0 130.4 

TP2-TP4 40 ± 3 18 3 142.6 11.69 131.8 155.0 

01' 02, 0101' 40 ± 3 18 4 144.2 14.74 123.8 155.0 0103 

T1-T3 40 ± 3 18 3 153.9 1.91 151.7 155.0 

RF11-RF20 40 ± 3 21 10 96.1 12.94 83.2 121.6 -~ ~ "-·-·-·-

SF1-SF10 40 ± 3 21 10 150.7 6.89 134.1 155.0 

GT1-GT3 40 ± 3 21 3 129.9 19.30 108.2 145.2 

GS1-GS3 40 ± 3 21 3 147.8 5.39 143.3 153.8 

VT1-VT3 40 ± 3 21 3 131.4 23.11 106.7 152.5 -~ ~ ~~ 

TP2-TP4 40 ± 3 21 3 112.1 15.05 96.1 126.0 

01-03 40 ± 3 21 3 155.0 0.00 155.0 155.0 

T1-T3 40 ± 3 21 3 152.5 4.39 147.4 155.0 

RF11-RF21 40 ± 3 25 11 73.9 3.62 66.6 79.9 

SF1-SF10 40 ± 3 25 10 116.9 19.06 84.4 149.8 

----~-

f--------G-1'4-GB--~- --40 ... ~ 25------- ~---a~--~- . --145-o-2----------45:-1-3-------- ---4-2-7~:& . ioJv.v "'"' " 

GS1-GS3 40 ± 3 25 3 116.6 22.23 91.5 133.7 

VT1-VT3 40 ± 3 25 3 107.9 30.86 74.3 135.0 

TP1-TP3 40 ± 3 25 3 86.7 10.72 78.3 98.8 

----~~ 

---~-04-00~ Ar\ + 3----2-S-- '2 1Ae:t_Q---- ---~-3-:2~9~~ r----142-;-~ -~-1-49-;0~~--

T1-T3 40 ± 3 25 3 138.7 2.46 136.6 141.4 

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-· ---- - ·--

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PEF<!PHEl:.(!\L Filter Migration Resistance in ~ ETR-04-03-02 

VASCULAR Comparison to Competitive Rev.O 

Product Phase 1 Page 6 of 13 

••••••• ••••••• 

................ ..... 

Tub¢ " fil~¢:1' -•·••·_F•••••••·-••···. st:ari(jari:J ••• .·.····················.> _.-.... -...... f··········· ;;:;;~_~_:_.:_~· . .:.;._ .............. · T~~tfn9 -·sample _ •..••. _._Mean·· Minimum•······ Maximum··-· 

I 8]" .. [. ·.~••-••••••••••• 1. Terl)p,_.·••· · Diameter·. •·•••-•:size•··-·• " {ffifrl.~g) p~yia~iqn _ .. _ .. ·. -.· ..• Jrl'lrfil-lg).•······ " (rl'j!'ill;lgf ••••.. 

••·•>(•cr•·•···•-•·• +@m) .. ·•·• (nJ (I'Jllllt-1~1······ ............... 

.. ::::-::-::<:· ·.> :····.· 

RF1-RF10, 37 ± 2 28 13 47.5 9.95 32.1 64.8 RF32-RF34 

SF1-SF10 37 ±2 28 10 76.3 12.16 65.0 105.8 

NMT1-NMT10 40 ± 3 28 10 55.7 5.11 47.1 63.2 

RF11-RF21 40 ± 3 28 11 51.3 6.53 43.8 62.9 

SF1-SF10 40 ± 3 28 10 89.1 13.23 73.2 108.3 

GT1-GT3 40 ± 3 28 3 89.6 6.00 83.2 95.1 

GS1-GS3 40 ± 3 28 3 89.9 11.46 83.1 103.1 

VT1-VT3 40 ± 3 28 3 76.4 22.79 62.4 102.7 

TP1-TP3 40 ± 3 28 3 42.7 9.90 31.7 50.9 

01-03 40 ± 3 28 3 136.6 7.37 128.1 141.3 

T1-T3 40 ± 3 28 3 122.9 21.09 109.0 147.2 

RF11-RF20 40 ± 3 30 10 39.6 7.98 26.7 53.8 

SF1-SF10 40 ± 3 30 10 92.6 24.02 63.8 138.8 

GT1-GT3 40 ± 3 30 3 78.4 23.26 57.1 103.2 

GS1-GS3, __A_Q_± 3 30 _ _3_ __ f---tQ2._5 ____ 4.10 98.3 106.5 1..:> .::> fUT "Gi::>li:ls---

VT1, VT3, 40 ± 3 30 4 74.9 17.93 51.1 93.4 VT1 01, VT1 02 

TP3, TP4, 40 ± 3 30 5 55.8 19.87 26.9 82.7 TP101-TP103 

01, 02, 0102, .-40.-±2- ___ _sQ_ ____ f--- ~-----~- 1n~ ::\ 1? ::\R 85 3 .-1-12--4--- 0103 

T1-T3 40 ± 3 30 3 96.3 12.46 84.2 109.1 

RF11-RF20 40 ± 3 32 10 34.6 5.43 25.8 43.2 

SF1-SF10 40 ± 3 32 10 79.4 15.76 56.5 112.7 

GT1-GT3 40 ± 3 32 3 90.2 14.36 74.1 101.7 

GS1-GS3, 40 ± 3 32 6 68.7 26.48 24.6 101.0 C:S ~(;1, GS103 ---·-·------- ··-- ---'-------'--------· 

VT1, VT101, 40 ± 3 32 3 58.9 16.83 47.5 78.2 VT102 

TP4, TP101- 40 ± 3 32 4 35.8 13.41 19.7 50.0 TP103 

02,0102, 40 ± 3 32 3 86.2 " _____ 10.12 _____ _____ I4J~~ ~93.2 01"0~ 

T1-T3 40 ± 3 32 3 73.6 10.74 63.8 85.1 

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Product Phase 1 Page 7 of 13 

NOTE: Reference appendix 2 for Statgraphics Plus 1 summary statistics, appendix 3 tabulated Excel2 

data/calculated averages for each filter, and appendices 4-10 for raw data_ 

1 Statgraphics Plus is a registered trademark of Manugistics, Inc. 2 Excel is a registered trademark of Microsoft, Inc. 

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8.0 ANALYSIS OF DATA 

8.1 Box-and-Whisker plots were generated to compare filter product for each simulated 

IVC diameter tube. 

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8.2 A summary graph was generated utilizing the average of each filter type for each 

diameter for comparative purposes. 

Figure 8. Filter Migration Resistance 

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Product Phase 1 Page 12 of 13 

9.0 DISCUSSION OF RESULTS 

Due to the small sample sizes of competitive product tested for migration resistance, statistical 

comparisons were not made. However, by looking at the plots in section 8 it appears as if the 

Recovery and Gunther Tulip Filters are comparable in regards to filter migration. All other 

competitive filters appear to have a higher migration resistance. 

It is important to note that there was a large amount of test variation. In a follow-up report, 

ETR-04-03-05, it was determined that the variation could be minimized by the following: 

• Introduce one simulated clot at a time. 

• Invert the sausage casing upon itself to create two layers and position the fold on the 

bottom of the simulated IVC where the casing is attached to the PVC piping. 

The Recovery Filter was retested in the 28mm diameter simulated IVC to compare to historic 

NMT data utilizing the changes to decrease variation. It is important to note that the mean 

value increased and the standard deviation decreased. 

Another study would have to be performed to determine the true statistical migration 

resistance differences or equivalencies between competitive filters. 

10.0 CONCLUSION 

The migration resistance of the Recovery Filter appears comparable to the Gunther Tulip Filter 

--------throughout alf simulated IVC diamete-rs. The other filters seemrol1ave a greater resistance fo _______ _ migration in comparison to the Recovery Filter and Gunther Tulip Filter. 

11.0 APPENDICIES 

~11--. ---!tM~o-ewrtowtoop-Migr atior 1 Test Fixture---- -------

2. Statgraphic Summary Statistics 

3. Excel Tabulated Data/Calculated Average for Each Filter 

4. 15mm Diameter Simulated IVC Raw Data 

5. 18mm Diameter Simulated IVC Raw Data 

6. 21 mm Diameter Simulated IVC Raw Data 

7. 25mm Diameter Simulated IVC Raw Data 

8. 28mm Diameter Simulated IVC Raw Data -----cc----=-=c--- --- --~~~---- ~~~ 

9. 30mm Diameter Simulated IVC Raw Data 

10. 32mm Diameter Simulated IVC Raw Data 

11. Filter Migration Digital Video Tapes 

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Appendix 1 New Flow Loop Migration Test Fixture 

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EXHIBIT 32 

Case 2:15-md-02641-DGC Document 8375-2 Filed 10/23/17 Page 32 of 120
From: 

Date: 

To: 

CC: 

Tessmer, Alex [/O=BARD/OU=TPE AG/CN=RECIPIENTS/CN=ATESSMER] 

3/24/2004 11:34:55 PM 

Benware, Charlie [Charlie.Benware@crbard.com], Fitzpatrick, Ed 

[Ed.Fitzpatrick@crbard.com] 

Hudson, Brian [Brian.Hudson@crbard.com], Carr, Robert 

[Robert. Carr@crbard.com] 

Subject: Starguide Filter Migration Test Results 

Attachments: Starguide.xls 

Charlie and Ed, 

I have shipped copies of the migration resistance test data sheets via FED EX overnight (tracking #634 7 6318 

7941). I have also attached an Excel spreadsheet with the raw data results and along with an average result for 

each filter. 

A total quantity of 40 filters were tested. Each filter was tested three times for a total of 120 runs. 

A quantity of 10 filters from each of the three ESM lots were tested (n=30 Starguide nitinol wire). A quantity of 10 

filters manufactured using the current supplier wire were also tested. 

You will quickly notice that there were values below the 50.0 mmHg acceptance criteria for all the three Starguide 

manufactured lots. Since this was the case, we tested filters manufactured using the current supplier wire to 

determine whether the issue was with the filters or the migration resistance testing. We quickly discovered that 

there were values below 50.0 mmHg when testing the filters manufactured using the current supplier. This points 

to the fact that there is an issue with the migration resistance testing. 

When we had previously tested the GFO manufactured filters to compare to historic NMT data, all data values 

were above the 50.0 mmHg acceptance criteria. The testing that was perfonned on the filters above utilized an 

identical test method. It is important to note that a new batch of sausage casing had been purchased to complete the 

testing. However, the operators did not notice any difference with the new casing in comparison to what had been 

previously used. The sausage casing was packaged the same and came from the same supplier. It had the same 

appearance, feel, and odor as the previous casing. 

In any case, more testing may need to occur before the Starguide nitinol wire should be approved. Perhaps we can 

test the radial expasion force of 10 Starguide manufactured filters to determine if the data is statiscally equivalent 

to the data we captured for the filters manufactured using the current nitinol supplied wire. Please contact Brian 

Hudson to discuss this issue further. 

Best regards, 

Alex 

Alex Tessmer 

Bard Peripheral Vascular 

Research & Development 

Engineer II 

1415 West 3rd Street, Suite 109 

Tempe, AZ 85281 

Direct: 480-303-2704 

FAX: 480-449-2597 

Email: alex.tessmer@crbard.com 

CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER 

LMD1 

% ellHtB\T NO•J.Q_ 

~ ~-

~ 

; ... \, "' \ \3 -

--

BPVE-01-00330122 

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Chad Modra

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 1

 IN THE UNITED STATES DISTRICT COURT

 DISTRICT OF NEVADA

KEVIN PHILLIPS, )

 )

 Plaintiff, ) Case No.

 )3:12-cv-00344-RCJ-WGC

vs. )

 )

C.R. Bard, INC., et al., )

 )

 Defendants. )

 )

 IN THE UNITED STATES DISTRICT COURT

 FOR THE NORTHERN DISTRICT OF GEORGIA

 ATLANTA DIVISION

PAMELA B. CASON and KERRY B. )

CASON, )

 )

 Plaintiffs, )

 ) Case No.

vs. ) 1:12-CV-01288-MHS

 )

C.R. Bard, INC., and Bard )

PERIPHERAL VASCULAR, INC., )

 Defendants. )

 )

 30(B)(6) VIDEOTAPED DEPOSITION OF C.R. BARD, INC.

 TAKEN THROUGH CHAD MODRA

 Phoenix, Arizona

 March 28, 2013

BY: KIM BATA, RMR/CSR

Certified Reporter 50233

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Chad Modra

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 181

1 Q. And then the event box it says, "RNF

2 product is placed on QA hold pending completion

3 of remedial action plan."

4 Do you see that?

5 A. Yes.

6 Q. What's a QA hold?

7 A. It's a control mechanism within our

8 distribution center that when we identify

9 something we want to investigate further, we

10 would place a QA hold on the product pending

11 that investigation.

12 Q. Okay. Does that mean it's not being

13 sold during that time?

14 A. Yes.

15 Q. Okay.

16 A. Yes, it means it is not sold.

17 Q. During the period that a hold is

18 placed?

19 A. That's correct.

20 Q. Okay. And is RNF Recovery? Is that a

21 Recovery Filter?

22 A. That would be my assumption.

23 Q. And do you know why a QA hold was

24 placed on the Recovery Filter on April 14, 2004?

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Chad Modra

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 183

1 send out the notification and they acknowledge

2 it and send it back that it's been placed on

3 hold.

4 Q. And is that a method by which to

5 ensure that none of those products were actually

6 being sold during the time that the hold is in

7 place?

8 A. Yes.

9 Q. Okay. Are physicians in the field

10 using the products notified that there's a hold

11 on the product?

12 A. No.

13 Q. So although Bard's not selling it,

14 they've placed a hold on it, physicians may

15 still be implanting it?

16 A. Yes.

17 Q. If you could turn to Bates range

18 ending in 2828.

19 A. Yes.

20 Q. The date entry is 4/25/2004, and on

21 the event box it says, RNF product QA hold is

22 lifted upon receipt of conclusions from HHE by

23 Dr. Lehmann, L-e-h-m-a-n-n.

24 A. Yes.

9 Q. Okay. Are physicians in the field

10 using the products notified that there's a hold

11 on the product?

12 A. No.

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