CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000 (REF 300029MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103162288), received between Feb 24, 2021 and May 12, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Degraded; Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND NINE (9) MONTHS DUE TO DEGENERATION AND CENTRAL REGURGITATION. THE PATIENT WAS PRESENTED WITH HEART FAILURE, DYSPNEA, AND CHEST PAIN. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS 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: Chest Pain; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 22006738 ↗
• InjuryOct 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 3000 PERICARDIAL VALVE IN THE PULMONARY POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE TPVR PROCEDURE WAS PERFORMED WITH A 26MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS NOTED TO BE IN RECOVERY 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: Insufficient Information

  MAUDE report 15655183 ↗
• InjuryJul 1, 2022Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT THIS PATIENT WITH A 29MM SURGICAL AORTIC VALVE, IMPLANTED FOR FOUR (4) YEARS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A 29MM 9600TFX.

  Patient problems: Insufficient Information

  MAUDE report 14886981 ↗
• InjuryFeb 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3000 AORTIC VALVE, IMPLANTED IN THE PULMONARY POSITION, UNDERWENT A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, 11 MONTHS DUE TO PULMONARY INSUFFICIENCY. THE TPVR WAS PERFORMED WITH A 29MM 9600TFX. ON POD #1, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 11373395 ↗