CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFX (REF 3000TFX23MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00690103163650), received between Apr 5, 2021 and Mar 6, 2026 — classified as 57 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 3300TFX PERICARDIAL VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24532711 ↗
• InjuryFeb 24, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24428932 ↗
• InjuryFeb 10, 2026Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTH DUE TO STENOSIS . THE PATIENT PRESENTED WITH HEART FAILURE. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11060A AORTIC VALVED CONDUIT. THE PATIENT WAS TRANSFERRED TO ICU POST PROCEDURE. PER PHYSICIAN ASSISTANT: PPM (EOA 1.9 CM2). EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Cardiogenic Shock; Heart Failure/Congestive Heart Failure

  MAUDE report 24306410 ↗
• InjuryOct 15, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 9 MONTHS DUE TO STENOSIS. THE PATIENT WAS ASYMPTOMATIC UPON PRESENTATION. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A VALVE. THE PATIENT WAS TAKEN TO THE ICU IN STABLE CONDITION POST PROCEDURE. PER MEDICAL RECORDS, THE PATIENT WAS ASYMPTOMATIC UPON PRESENTATION. PRE-OP TTE ((B)(6) 2025) REVEALED SEVERE STENOSIS WITH EF OF 55-60%. REDO STERNOTOMY WAS PERFORMED TO EXPLANT THE PREVIOUS 23MM MANGA AORTIC VALVE. INTRAOPERATIVE TEE FINDINGS WERE AS EXPECTED, SEVERE STENOSIS AND SEVERE LEFT VENTRICULAR HYPERTROPHY. THE PREVIOUS VALVE WAS EXPLANTED AND THE AREA WAS DEBRIDED. THE SURGEON WENT TO PLACE A 23MM INSPIRIS VALVE BUT FOUND THAT THE LEFT MAIN CORONARY OSTIUM WAS OBSTRUCTED BY THE SEWING RING. THIS PROMPTED THE SURGEON TO REMOVE THE 23MM INSPIRIS AND REPLACE THE AORTIC ROOT WITH A 23MM KONECT VALVED CONDUIT INSTEAD. ONCE OFF BYPASS, THERE WAS MILD TO MODERATE RV DYSFUNCTION. PRIOR TO LEAVING THE OR, THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION ON SEVERAL OCCASIONS AND WAS DEFIBRILLATED EACH TIME SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304835 ↗
• InjuryOct 15, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23 MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A 23 MM 9755RSL VALVE WITH GOOD RESULT.

  Patient problems: Insufficient Information

  MAUDE report 23280205 ↗
• InjuryAug 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000TFX VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION AND RECOVERING POST-PROCEDURE. PER SURGEON THE SURGICAL VALVE FAILED DUE TO PROGRESSION OF DISEASE AND DID NOT FAIL EARLY.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 22912472 ↗
• InjuryAug 27, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 6 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH SOB, SWELLING/EDEMA, LIGHTHEADED, AND FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED POD #8. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Dyspnea

  MAUDE report 22905524 ↗
• InjuryAug 1, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, EIGHT (8) MONTHS DUE TO SEVERE STENOSIS. PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE - SHORTNESS OF BREATH, CHEST TIGHTNESS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY. PATIENT WAS IN STABLE CONDITION POST PROCEDURE. PATIENT WAS DISCHARGED ON POD #1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22688399 ↗
• InjuryJun 10, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 23MM 3300TFX AORTIC VALVE IMPLANTED (B)(6), WAS BEING EVALUATED FOR VALVE-IN-VALVE PROCEDURE DUE TO SEVERE AORTIC STENOSIS. PATIENT PRESENTED WITH HEART FAILURE. PATIENT EXPIRED DUE TO UNKNOWN REASONS.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22177081 ↗
• InjuryMay 19, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000TFX VALVE, IMPLANTED IN AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS AND 8 MONTHS DUE TO CALCIFICATION AND RESTRICTED MOTION.

  Patient problems: Insufficient Information

  MAUDE report 22047656 ↗
• InjuryMay 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE IMPLANTED IN THE PULMONIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS RELISA AORTIC VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22039516 ↗
• InjuryMay 16, 2025Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 4 MONTHS DUE TO CONCERN FOR ENDOCARDITIS, WITH DEGENERATION AND SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS IN ICU POST PROCEDURE PER ROUTINE. WAS DISCHARGE FROM HOSPITAL POST SURGERY ON POD # 7. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL CUSTOMER COMPLAINT. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Endocarditis; Heart Failure/Congestive Heart Failure

  MAUDE report 22039070 ↗
• InjuryMay 14, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, ONE (1) MONTH DUE TO SEVERE STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE - SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PROCEDURE WENT WELL WITHOUT ISSUES AND PATIENT WAS TAKEN TO THE ICU POST PROCEDURE.

  Patient problems: Cardiogenic Shock; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 22020432 ↗
• InjuryApr 25, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO CALCIFICATION AND SEVERE STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE PATIENT WAS DISCHARGE ON POD#4. PER PATHOLOGY REPORT, PROSTHETIC AV WITH 3 CALCIFIED LEAFLETS.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 21911250 ↗
• InjuryApr 25, 2025Degraded; Degraded

  IT WAS REPORTED AND LEARNED FROM MEDICAL RECORDS THAT, THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS DUE TO SEVERE DEGENERATION WITH STENOSIS AND SEVERE INSUFFICIENCY. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE NYHA CLASS 3. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE, EXAMINATION AND IMAGING REVEALED SEVER BIOPROSTHETIC AORTIC VALVE DEGENERATION WITH BOTH INSUFFICIENCY AND STENOSIS. THE PATIENT UNDERWENT TAVR USING 23MM 9755RSL SAPIAN 3 RESELIA TRANSCATHETER VALVE INSIDE THE FAILING 23MM 3300TFX MAGNA EASE AORTIC VALVE. POST-PROCEDURAL TEE DEMONSTRATED WELL SEATED PROSTHESIS WITH NO STENOSIS NOR INSUFFICIENCY, MEAN GRADIENT OF 2 MMHG. THE PATIENT TOLERATED THE PROCEDURE WELL AND TRANSFERRED TO THE PACU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON POD #2.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21910832 ↗
• InjuryApr 18, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE IN AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 8 MONTHS DUE TO CALCIFICATION AND REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD # (B)(6). EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21868684 ↗
• InjuryApr 2, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO STENOSIS AND REGURGITATION. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21753444 ↗
• InjuryMar 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 3000TFX 23MM AORTIC VALVE IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 21722144 ↗
• InjuryMar 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21596845 ↗
• InjuryMar 3, 2025Calcified; Inadequacy of Device Shape and/or Size; Calcified; Inadequacy of Device Shape and/or Size

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF OVER 7 YEARS DUE TO PPM AND STENOSIS. THE PATIENT PRESENTED WITH SOB. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS DISCHARGED POD #7. PER MEDICAL RECORDS, THE PATIENT HAS HAD FATIGUE FOR OVER A YEAR WITH DYSPNEA ON MILD EXERTION. ECHO WAS DIFFICULT DUE TO BODY HABITUS. ECHO REVEALED PEAK AND MEAN GRADIENT OF 76MMHG AND 47 MMHG RESPECTIVELY WITH SUSPECTED DYSFUNCTION OF PROSTHETIC VALVE. REDO STERNOTOMY WAS PERFORMED WITH AVR AND AORTIC ROOT ENLARGEMENT. PROCEDURE WAS UNEVENTFUL, HOWEVER, UPON WEANING CBP PEAK GRADIENT WAS ABNORMAL. THE HEART WAS RE-ARRESTED, AND PANNUS WAS REMOVED. PATIENT TOLERATED THE PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS. PER PATHOLOGY REPORT, THE BIOPROSTHETIC VALVE WAS WITH SEVERE CALCIFICATION WITH LIMITED MOBILITY OF THE CUSPS. MODERATE PANNUS FORMATION, BUT NO TEARS, VEGETATIONS, OR PERFORATIONS ARE PRESENT. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROS

  Patient problems: Dyspnea

  MAUDE report 21508592 ↗
• InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 25MM 11500A AORTIC VALVE AND 29MM 7300TFX MITRAL VALVE IMPLANTED EIGHT (8) YEARS, WERE EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICES WERE REPLACED WITH A 25MM 11500A AORTIC VALVE AND 29MM 11400M MITRAL VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL CUSTOMER COMPLAINT. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21325796 ↗
• InjuryFeb 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT UNDERWENT DOUBLE REDO VALVE REPLACEMENT. A 23MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS DUE TO SEVERE PARAVALVULAR LEAK AND DEHISCENCE ALONG THE SUTURE LINE CORRESPONDING TO THE LEFT CORONARY CUSP. THE PATIENT WAS ASYMPTOMATIC. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS DISCHARGED ON POD #3. PER MEDICAL RECORDS, TEE SHOWED ROCKING OF THE PROSTHETIC AORTIC VALVE WITH LARGE PVL AROUND THE AREA CORRESPONDING TO THE LEFT CORONARY CUSP. THE AI JET EXTENDS TO THE COAPTING MV LEAFLETS CREATING TURBULENT FLOW BELOW THE MITRAL ANNULUS. THE PATIENT UNDERWENT REDO AVR AND MVR. INTRAOPERATIVELY, THE PREVIOUSLY IMPLANTED AORTIC PROSTHESIS WAS FOUND DEHISCED ALONG THE SUTURE LINE CORRESPONDING TO THE LEFT CORONARY CUSP. THERE WERE NO SIGNS OF INFECTION. THE LEAFLET INTEGRITY WAS NORMAL. THE OTHER PORTIONS OF THE VALVE WERE WELL INCORPORATED. THE 23MM VALVE WAS EXPLANTED AND REPLACED WITH A 25MM INSPIRIS VALVE. THE PREVIOUSLY IMPLANTED MITRAL VALVE WAS EXPLANTED AND REPLACED WITH A 29MM MITRIS VALVE. SATISFACTORY FUNCTION OF THE NEWLY IMPLANTED PROSTHESES WAS NOTE

  Patient problems: Insufficient Information

  MAUDE report 21314465 ↗
• InjuryJan 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 3000TFX 23MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 25MM AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21283217 ↗
• InjuryJan 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY EIGHT (8) YEARS, FOUR (4) MONTHS DUE TO CENTRAL REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE - SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY AND PATIENT WAS IN STABLE CONDITION POST PROCEDURE. THE PATIENT WAS DISCHARGED ON POD #1.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 21161628 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 1 MONTH DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 20895671 ↗