CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFX (REF 3000TFX19MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103163636), received between Apr 12, 2022 and Aug 8, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Gradient Increase” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 19MM 3000TFX AORTIC VALVE IN AORTIC POSITION UNDERWENT A VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, 10 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. AVR WAS COMPLETED WITH A 21MM 11500A AORTIC VALVE.

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

  MAUDE report 19937295 ↗
• InjuryJul 26, 2022Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 19MM AORTIC VALVE IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 7 MONTHS DUE TO SEVERE STENOSIS AND MILD REGURGITATION. THE PATIENT PRESENTED WITH SEVERE SOB AND ACUTE DIASTOLIC CHF. THE PATIENT HAS A HISTORY OF AS, CHF, PULMONARY HTN, HTN, HLD, DM, BREAST CARCINOMA, AND FORMER SMOKER.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 15103662 ↗
• InjuryJul 12, 2022Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT THIS PATIENT WITH A 3000TFX 19MM VALVE, IMPLANTED FOR FOUR (4) YEARS AND 10 MONTHS, IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE DUE TO AORTIC STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 14988102 ↗
• InjuryMay 21, 2022Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close; Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 3 MONTHS DUE TO AORTIC STENOSIS. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE SUCCESSFULLY. THE PATIENT DID WELL.

  Patient problems: Cardiogenic Shock; Insufficient Information

  MAUDE report 14466622 ↗
• InjuryApr 12, 2022Gradient Increase; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Gradient Increase; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 3000TFX 19MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED FOR THREE (3) YEARS AND SEVEN (7) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 3300TFX 21MM BIOPROSTHETIC VALVE. PATIENT POST PROCEDURE IN RECOVERY. 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; Insufficient Information

  MAUDE report 14090961 ↗