CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFX (REF 3000TFX29MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00690103163681), received between Jul 19, 2021 and Apr 4, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2026Device Stenosis

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11500A VALVE. THE PATIENT WAS STABLE POST-PROCEDURE AND WAS DISCHARGED ON POD #4. 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 24786561 ↗
• InjuryOct 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 8 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A VALVE. PER ADDITIONAL INFORMATION PATIENT EXPIRED ON POD#1.

  Patient problems: Insufficient Information

  MAUDE report 23326314 ↗
• InjuryFeb 19, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3000TFX UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, TWO (2) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN. THE TAVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE AND IN RECOVERY POST PROCEDURE.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 21414649 ↗
• InjuryJul 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A INSPIRIS RESILIA 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 19670001 ↗
• InjuryJan 7, 2024Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT 29MM 3000TFX AORTIC VALVE WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, TWO (2) MONTHS DUE TO AORTIC STENOSIS AND INSUFFICIENCY. THE TAVR WAS COMPLETED WITH A 29MM 9600TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 18461427 ↗
• InjuryJul 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED FROM THE IMPLANT PATIENT REGISTRY THAT A MODEL 3000TFX 29MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 29MM VALVE AFTER AN IMPLANT DURATION OF 4 YEARS, 4 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 17361912 ↗
• InjuryOct 20, 2022Gradient Increase; Gradient Increase

  EDWARDS RECEIVED INFORMATION A PATIENT WITH AN EDWARDS MAGNA VALVE IMPLANTED FOR APPROXIMATELY SIX YEARS IN PULMONARY POSITION UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO HIGH GRADIENT. A 26MM S3 ULTRA TRANSCATHETER VALVE WAS IMPLANTED INSIDE THE SURGICAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 15639982 ↗
• InjuryDec 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS FILE WAS FOUND TO BE A DUPLICATE OF FILE CASE: 2021-18913. THE INVESTIGATION OF THE EVENT WILL BE PERFORMED UNDER 2021-18913. THIS FILE WILL BE CLOSED. IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS PATIENT WITH A 29MM 3000TFX VALVE, IMPLANTED APPROXIMATELY FOR 14 YEARS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. THE TAVR WAS PERFORMED WITH A 9600TFX 29MM.

  Patient problems: Insufficient Information

  MAUDE report 12928574 ↗
• InjuryNov 24, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3000TFX PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 13 YEARS, 11 MONTHS DUE TO STENOSIS AND INSUFFICIENCY. THE TAVR WAS PERFORMED SUCCESSFULLY WITH A 29MM 9600TFX TRANSCATHETER VALVE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12868598 ↗
• InjuryNov 13, 2021Degraded; Fluid/Blood Leak; Gradient Increase; Insufficient Device Problem Information; Degraded; Fluid/Blood Leak; Gradient Increase; Insufficient Device Problem Information

  THROUGH THE IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 29MM 3000TFX PULMONARY VALVE IMPLANTED FOR 11 YEARS, 7 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO SEVERE SYMPTOMATIC PULMONARY VALVE DYSFUNCTION. THE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE. THE DEVICE WAS REPLACED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON POD #1 IN A STABLE CONDITION. 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 12808219 ↗
• InjuryJul 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3000TFX PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, NINE (9) MONTHS DUE TO REGURGITATION. THE TAVR WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12192921 ↗