CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFX (REF 3000TFX27MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00690103163674), received between Jul 16, 2021 and Sep 15, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, NINE (9) MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY. PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23057547 ↗
• InjuryAug 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3000TFX PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, ONE (1) MONTH DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22923886 ↗
• InjuryAug 8, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO DEGENERATION WITH SEVERE STENOSIS AND REGURGITATION, AND AORTIC ARCH DISSECTION. THE PATIENT PRESENTED WITH HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. THE PATIENT LATER EXPIRED WITH UNKNOWN DATE AND CAUSE OF DEATH. PER MEDICAL RECORDS, THE PATIENT UNDERWENT REDO-AVR WITH ASCENDING AORTA AND AORTIC ARCH REPLACEMENT USING A 27MM 3000TFX AND A 30MM GETTINGE CARDIOROOT GRAFT AND 30MM HEMASHIELD GRAFT.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 22758119 ↗
• InjuryNov 10, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 3000TFX AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS AND EIGHT (8) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN. THE TPVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON POD #1.

  Patient problems: Chest Pain; Dyspnea; Insufficient Information

  MAUDE report 20649142 ↗
• InjuryAug 5, 2024Degraded; Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS DUE TO DEGENERATION. THE PATIENT WAS ASYMPTOMATIC. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. PATIENT IN STABLE CONDITION POST PROCEDURE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906401 ↗
• InjuryMay 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 3000TFX PERICARDIAL AORTIC VALVE UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, ONE (1) MONTH DUE TO UNKNOWN REASONS. THE REPLACEMENT VALVE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19251388 ↗
• InjuryDec 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS PATIENT WITH A 3000TFX 27MM VALVE, IMPLANTED FOR 11 YEARS AND TWO (2) MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. THE TAVR WAS PERFORMED WITH A 9750TFX 26MM. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 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 12937901 ↗
• InjuryDec 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE IS NO INVESTIGATIONAL EVIDENCE THE SURGICAL VALVE PREMATURELY FAILED/MALFUNCTIONED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 12925426 ↗
• InjuryNov 2, 2021Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3000TFX PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, SEVEN (7) MONTHS DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12741128 ↗
• InjuryOct 11, 2021Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  EDWARDS RECEIVED INFORMATION A PATIENT WITH A 27MM AORTIC VALVE IMPLANTED FOR AN UNKNOWN IMPLANT DURATION UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. A 23MM TRANSCATHETER VALVE WAS IMPLANTED INSIDE THE 27MM VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 12606790 ↗
• InjurySep 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3000TFX PERICARDIAL VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 10 YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE TPVR WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12423302 ↗
• InjuryJul 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3000TFX PERICARDIAL VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, 10 MONTHS YEARS DUE TO REGURGITATION. THE TPVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12185534 ↗