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AFFIDAVIT (mai femrcor resurer Mists esmein Tee me Sion Min, CSO se caper oie Dope Heth nd Fm ‘Seu ond ae ion Segue he rt abort A funy 1, 125,43 Seen ‘alas W Rerpation Pa. V, Sens 1215 eee ate 140 Renin Pn No 11953 S19, (eee pl 153 nl es, Soe 509, 98 States al Lange 6320 U.S 308 tev My 4, 19 wader ‘etke oaths aims, aaa yesoalyappered Nalin M. Roamer, MD in Teco and ate ani ho, ing dy Sm, eps andy am the Medical Ditector at Most Sacred Heart of Jesus Cardiology and Valvular Insitute, 703 North Sth Street, Sheboygan, WI 53081, 920-451-4611; and, was an Assovate Professor at Northwestern University, Chicago IL from 2000 to 2011. I canbe reached at 312-498-9496 (cell) ‘On 12/10/2018 I came to the U.S. FDA Minneapolis District Office (MIN-DO), 250 Marquette Ave, +4600, Minneapolis, MN 55401 to report a patient death elated to a heart valve implanted under research conditions, [was accompanied by the son of the patient and local news representatives, and ‘we were stopped, I subsequently sent an email to Michael Dutcher, DVM and District Director of MIN-DO regarding “Reporting an Adverse event today”, I was contacted by Sheila vanTwuyver, Consumer Complaint Coordinator for MIN-DO on 12/11/2018, and I subsequently provided the following written statement to he. (On 12/11/2018 I provided the following information in an email to Ms, vanTwuyver: “URGENT: IMMEDIATE ATTENTION FOR FDA INSPECTORS! December 11, 2018 Dear Sheila “Thank you for your prompt response “The Knotts family suffered the worst lots on Thanksgiving Day, the death of thet beloved husband, father and grandfather secondaty tothe failed heat surgery of « miteal valve repair on September 25, 2014, Williams Knotts recived a 34 mm physio ring during surgery st Northwestern Memorial Hospital by Dr, Patrick MoCatthy. After surgery, the Mr. Knots never felt well. He was shor of breath with ‘exertion andl at rest forthe next three and a half years, and never received answers to why he had ‘continued symptoms. Zh a on pay Smet POT c ed teh Po Ta rE eter Ssbacibet and vera to beore meat MBO=EPIS MA ns 1 day o_o yr Shown To oa oT Tas Sa aA Tay 39 Reon Poa VTE Io, Reon Pa 195, ative pl 1, 98 ans PL Des een a 1980 “SRIF 535 (7) eT FaSSTA AFFIDAVIT ie fmreor ea mente Heme Bef me Siroe Maan, C50 ‘ome Darien of ee Han ‘Seve. Fo ard Dg Ada ign ye Sis, dro he Ato ana 1 125, 4 She ‘nang: Ramee Ph No.1, Ser 1215 fie fae 198; Reriion Pan No.1 153, Ss. 19, hte api 1 955 nd PL 96, Se 30,93 Ste Lage 5650 USC 350 eee Mays 199 wader Ce tk at fiat, nafs, psoraly peared Nalin Maan, MD a ‘Secon and sifting lyse, dep ys When Mr. Knotts left the operating room on September 25,2014, the surgery performed by Dr. Patrick MeCarthy. See Attached operative note. When he lef the operating room, Mr. Knotts had a gradient ‘cross the mitral valve of 12 mm Hig, Normal should be less than mm Hg. ‘This gradient was measured and confirmed at various institutions including University of Chicago, the “Mayo Clinic and also during the heat surgery at Nortbwestem Memorial Hospital, [After years of shortness of breath, Mr Knotts consulted with myself on April 25, 2018, and T recommended that he get severl opinions regarding the severe mitral stenosis resulting from the first ‘surgery. After consultations with several surgeons, Me. Knots chose to go to Christ Hospital in Caklavin, IL to have a second surgery to remove the diseased valve. ‘The second surgery occurred on June 1, 2018 and he was inte operating room for 12 hows with cpisodes of cardiac ares, He then was inthe hospital fo 174 days and transferred to Shirley Ryan rehab in November 2018, and then died in te intensive care unit at Northwestexn Memorial Hospital ‘seeondaty t0 bleed inte his bean on Novernber 22,2018 (On November 24, 20181 informed Northwestern University IRB, President of Northwestern U, the ‘zener counsel the board of trustees ct. of the death ofthe patient as Mr. Knots had an experimental protoeol performed during the September 25, 2014 surgery. A protocol which was recently discovered fo be aferminated Northwestem FDA IRB protocol from 2007, as discovered by FDA Inspectors on ‘August 8, 2008. ‘Upon review of Me, Knotts operative record on September 25,2014, he had undergone a technique to measure the patient's ital valve leaflet using a caliper 1155 as outlined inthe attached memo submitted tothe United States Senate Committe. “The company Edwards Lifesciences had developed the caliper for measurements of the thee sallops of the antevior(ront) and postriortback) leaflets of the mital valve. The specific measurements are AL, ‘A2,A3 end PILP2.3, YL Boa 0 RE mer ee subcribe nd worn t before meat, Mines MO - —— “Eye DSH wl Ta ae el wk Fea Tay, 195. Reason Mn ne e315; Resa PN To 159 fate Al 1 9S and PL, NOSE fv May 98, ‘AFFIDAVIT iad near Sor Minne ea Def ma San. Maen C50. “ele a egret of Head ian ‘Seni Fooarl ras Asian egal by Seay, an may ft Ato ray 3, 905, 4 Sates tage 6% Reoprnon Pi 1 Sos 1 ave ae 30,10; Region Pn, 195, Ses. 1, (Sete Ap 95% and PL eh, Sep. 93 Sata Lage 95 29 USC 3508 fern My 4980 odie fr ak oh ffimaan, and lsh, poly appeed Na M, Raj, » Geomay dame cnia wn bebe uly wom ageernisy “These measurements were specific to 8 protocol 1532-004, atached tothe Senate Judiciary Committee leticr, March 2014, which Dr, McCarthy had developed to measure the valve during a prospective clinical tal to repr myxomatous mitral valve disease, or mitral valve prolapse, se attached publication of July 2008. | was a member ofthe study team and helped to write the frst report, see attched, but removed my participation in May 2007. At this time, I leamed ofthe first vstim, Ms. Vlahoulis, who needed a ‘Second heart surgery and that she had never signed a form for consent io be in the prospective tr In May 2007, I reported the event ro Northwestem University IRB, Northwestem Memorial Hospital, and the Dean’s office. The University’s IRB coordinator Ms, Osafo, reviewed the protocol in May 2007, and asked the surgeon Dr, MeCathy to cease and desist the protocol 1532-004, The protocol ineluded prospective stdy on the patients esting of the model $100 ring and the use ofthe 1155 caliper ‘measurements, Since Dr, MeCaathy chose to terminate the ‘sty, see attched record, and not submit the proper paperwork to follow the FDA IRB regulatory pathway for reporting prospective testing ofa heat devices and the measurement technique cited under the IRB protocol 1532-004 Dr. MeCarthy instead of complying with his own termination order, he continued to perform the caliper ‘measurements on severe patients at last until year 2014 as recorded in Me. Knotts operative report, i ino yeat 2018, which included hundreds ifnet thousands of patients 1 know of four other patients who have suffered severe side effect fom the failed mitral valve repair surgery, who have constited in my practice in Chicago and in Wiseonsin. These patients have had heart tacks and reoperation, and all of them heve also needed pacemakers und defibillators ete from the ‘damage sustained during the surgery "Now thatthe Knotts’ 2014, operative record proves that Dr. MeCarthy continued wo perform the caliper measurements after the University IRB coordinator issued the cease and desist on June 28,2007, and Ye yf we salar Poe few Coy at pane fe ew Mansy sera to before me a : AFFIDAVIT mee fae ra Monona Tin Bi aig Dae my ot Aen 2 89 Fae oe ce ne stage: Remit Pe i. ates as ASUS 380 Nay LO Ca A aioe af ein yenoaly ppt eM. amen MD cr tii ace vi ects io has av die FDA must tak iniediate tion to vestige he os Ne. Kets he san, Ober, ito hove teed nm reaperatins das nd et Vth al ty of Marc 206 ll of whom lo received th exptine eA mis ac loeb Oso on June 28,2007 fr not eporing he prsmetve ate oS ‘lima study wich began in March 2006 In2018, dere coud else o 2000 patients who may have go the triad apse caliper ronan 1532-004, whic could have sized the ing Incase s Dr, Neat failed to follow Feta published Directions fr Ue or annuloplasty rings, wih raced his ad ling to fellow Northwestern Univesity FDA TRE czas an dei ore. “The mediate ation bythe FDA shouldbe to 1) place old on he terminated Proersl 1532-004 and Fre ln a of Dr MeCarty's pas curt and tre surged, 3) 00 ‘irl valve 2 eds wich pled ptt tisk for tosis, ea tacks, reoperation eaths and 4) t0 re Sar and desist order on all IRB rssrch posts for Dr. McCay, Whe fale to follow Ba ty ata) a cuived by Nornwestem Universi he FDA and ao ives Titesciences and has caused deaths as event as Noverber 22, 2018, bipsufow. tin golScinseResearhSpesa opi RonsingC nia ialCampineEsloreensn ‘uct 369514.4m steven Knits resident of MN whose father ded on Thanksgiving fam te femintet experimental etacl which Edvard Lifescences never opted inte desis foros FT FDA cleared rearing aed melo nave Minessan and Adjunet physician lenis 6 ‘Mayo Clinic, annuloplasty es omy Brust shoo! waning the Mayo Cini ince 1985, an TRS apetience a the Mayo Cline and Noehvrestem Universi can Serer eth you this week atthe FDA in your Minneapolis to review the evidenes “rc evktnes i cae hrs was erin y RB corte Onn May 207 bse | Yew we sre ORR eS ne ans Ea ie Gs tt ak dp at BO TGabmcrved and prorat before me at, METOEEPCES MIN 19 Decent ie aay | Sg oT TTT on Ta Raney A og Be of ete Ah 1 93. Ses eee Noy FoR tee GOTH AFFIDAVIT aaa fara wor Behe ey” Sato Ma, 30) cgi Depart ath a Huan ‘Seven Fosse Dg Adina egal ye Sere, wr mor) othe At Inn 31,1928, 1 Suatte Lage 603; Reorpnicaton ano, Sv 12-5 fle tne 140 Rerniznn Pan No. of 195, See. 1, ‘Hocre Apt, 1855 nd PL eth, Se, 93 Sates Lara 65 QDS 3508) eee May 4, 980; sr nk oath, tia ati, paso appeared Nal M- Rajan, MD By ‘eco arate sri hig dys, dees ay ‘MeCarthy failed to identify the prospective nature ofthe clinical esearch trial, patients have been injured with recent death a reported tothe University on November 24,2018, ar now to the FDA, and there may be thousands of patents who were asleep under anesthesia, since 2006, who never knew they were experimented on withthe calipers, and who should have received the confirmed FDA approved Directions for use which was approved by the FDA. Tor the Edward Lifesciences Sizing instructions for annuloplasty rings. “Thank you again for your prompt response and I hope the FDA places an immediate hold on the protocol 1532-004 experimental sizing measurements to protect fur patient from being injured and ‘or succumbing to death from the filed repair. [Nalini Marie Rejamannan, MD, ACC “Most Sacred Heart of Jesus Cardiology and Valvular Instat Corvita Seience Foundation “Mayo Cline Department of Biochemistry and Molecular Biology” (On 12/12/2018 at 11:40 AML provided the following additional information in an email to Ms, vvanTwuyver, copied to several individuals including representative at Kare I news, the U.S. Senate, and US. House of Representatives: “Dear Sheila One quick clarification, al ofthe vietms thought they were receiving the standard of eare from Dr McCarthy, “They were told they would get FDA cleared annuloplasty rings with the FDA approved directions for AA ofthe victims listed including Me Knots father got the measurements outlined inthe 2006 1532-004 protocol, which Northwestern IRB terminated officially on June 28, 2007 1 Daye ORS Gage Oa Fm pay am SP ee “spy [Scribe nd sworn etre mete, MN ig 19% me see a ; 43 Eis of Dans a ea a as Sees Signe A Tay, 1. Reraneon Pn TV te San 30, 180; Renton Pan No of 15h ellcve Ap 1983; 6 eve My 4H, ORI FOR as TY rors Fa AFFIDAVIT jem ao Mina Henmepn etree, Sea Mabon C30 {a snot Deprenen of Held an Seven ud and Dg Aira eign We Seny cra ofhe Ato ay 311525. Snes sng 8: Regnenion Plan Ne ¥, Ser 12-1 eee ne 0, At Resanznion Pan No 11883, Se. 14, Ctiecve Api 1,195 ong PL 96K Sx 5,93 Sie at Lape 29 USC. 808 eee May 4, IB; wie te uh ot, frais, nda, pero part NAHM. Rasonnn, MD in ‘Se unt ie esi who beg dy ver dees a ‘The failure to follow the Edwards Lifesciences DFU isthe cause of Mr Knotts death, We are available to meet at your office to review the evidence. Nalini Rajamannan, MD" Later on 12/12/2018, at 7:17 PM I provided the following addtional information in an email to Ms, vanTwuyver: “Dea Sheila Please convey to the investigators, thatthe caliper measurements were never approved by Edwards Lifesciences and the FDA 510k clearance forthe annuloplasty rings manufactured by Edwards Lifesciences | am attaching the diretions for use forthe mode! $100, ‘The caliper measurements were part ofthe experimental protocol Northwestera University had terminated back on June 28, 2007 ‘Any patient who underwent mitzal valve surgery and the surgeon used the Edwards Lifesciences rings, the correct operative technique would be to ue the standard sizer which is listed inthe DFU on the attached documents | have 5 patients who have been injured, and one who ded. There is another patient who recently died, and who underwent a mittal valve surgery by the surgeon from Northwestern Univesity Nalini™ ee fe - Mn OE Tay eS gw IN, wee Shey [subscribed andsworn ta beare me at, Mines MN nis 190 dy ot Dezember | Bsc Dp oa al Honan Seeded alt At Tina 3,135, Regan Pow eRESve | deo 1 Rung Pha Ne 183, lee Ap 1 193 at PL 6 ie ay 18, RMT FOR a5 OTT aon FRET AFFIDAVIT bio ‘be ey Sar Mason C5" ‘wget Dperinar of Hei Haman Series Fob Dig Adio, guise Ss nero he Ac fay 31,1925, 49 Sates {trp 1 Ronsnion Pn N,V, Se. 1, ofeie Je 30, 0: Renin Pn No, 1 1983, Se. 1, ‘Stn Al 1 98s 368 Se. 09,53 Sates at Larges (2 USC. 3509 eee May 4 1980; ain Graken and fois, pel appeared Nal Maja MD in "ecm se res ho being J sm. eons and attached the following documents to that ems: device model $100 dreetions for tse titled “Edwards Myxo ETlogix Annuloplasty Ring implantation Techniques", dated 2007 (14 pages); and, Trademark information forthe Myxo Etlogix device, showing Registration Date Jan. 5, 2008 owned by Edwards Lifesciences Corporation, One Edwards Way, Irvine, CA 92614, On 12/19/2018 | met withthe FDA Biorescarch Monitoring (BIMO) West Program District Director Eric Pittman and Consumer Safety Officer Sharon Matson at MIN-DO to provide additional desis of my eoncerns, documents, and to request follow-up by FDA. I was accompanied by Steve Knotts, ‘Minneapolis; MN, son ofthe deceased paticnt Bill Knotts; Chess Obermeier, California, husband of a patient Maureen Obermeie; and, Brian Warshawsky, California, patient. {believe Dr. MeCarthy continued his prospective experimental protocol 1532-004 using an unapproved mnt valve caliper measuring tol after he was told to stop by his reviewing IRB on 6/28/2007; that the tse of the calipers instead ofthe standard sizing device led to mis-szing of mitral ring which has led to serious adverse events for pitients inching death; and, !am extremely concemed that he continued and is continuing in these procedures with other patients, This is also the Sth clinical trial Dr ‘MeCoarthy has conducted without getting patient informed consent, hat 'm awate of, with the others being a Batista study, Atrcure, Edwards Model 4100 study in addition tothe Edwards Model 5100 and calipers Model 1155, | identified and provided copies ofthe documents to FDA as described in this statement. Thave feviewed this affidavit and affirm itis tue and accurate. mn \we een) Coy aw oe py CAS eT Dood subscribed and sworn to before nen Meo MN ; ee ae Ea a Din oT a Han See eps an taney 15. Re hme 1 Kempen PN Tot sf Ap 18S ao PL MAR eR Mey 810, RFD a TE Sane PRISE AFFIDAVIT a Manet nea Teles _ Sar Wn Taupe Dron of on Hanan Sues ood Dig Admini, dened he esl he Act any 3152543 Sates Lanett: Rerpnton lan NV Sec 15 ecient 3014, Reresaion Pn N.of 1953, Ses. 13, Hive Ap, 1953 a P9648, So US, 93 Sater Large 565 (21 USC 350 ete My 10 der ke a, tration, a ais peel appear Nali MR MD 5 ‘Secomyand ste afoul vin, bingy orem pesesandags gar Ye. mI sa Re PT a wo fp Sa ~ egal ston pw phe we S04 Subscribed und sworn to before me at Minoesoetis MN —_ 7 5 this day of December 2018 Tg of Dern a dT ST ET ARTA a ny, 198 Renan Pan AER ane 810 Romp PNT 15 ate Ap 1,185 aa PL Se ete dy ON,