CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000 (REF 300019MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103162233), received between Mar 18, 2021 and Sep 22, 2026 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

• InjurySep 22, 2026Insufficient Device Problem Information

  It was learned through Implant Patient Registry that a patient with a 19mm 3000 aortic valve was explanted after an implant duration of 9 years, 1 month due to unknown reasons. The explanted valve was replaced with a 19mm 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 50853556 ↗
• DeathMay 11, 2026Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 3000 19 MM AORTIC VALVE IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 11 MONTHS DUE TO CALCIFICATION, STENOSIS, AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. THE PATIENT EXPIRED (B)(6) 2026 DUE TO BIVENTRICULAR FAILURE AND LIKELY CARDIOGENIC SHOCK C/B MOF AND LACTIC ACIDOSIS.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25137249 ↗
• InjuryNov 16, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 19MM 3000 AORTIC VALVE IMPLANTED FIVE (5) YEARS, ONE MONTH, WAS EVALUATED FOR VALVE-IN-VALVE PROCEDURE DUE TO AORTIC STENOSIS. IT WAS LEARNED PATIENT IS NOT A CANDIDATE FOR VIV. PATIENT HAS BEEN SCHEDULED FOR REOPERATION AND LIKELY ROOT REPLACEMENT. PATIENT PRESENTED WITH SHORTNESS OF BREATH, LIGHTHEADEDNESS, AND EDEMA.

  Patient problems: Dizziness; Dyspnea; Insufficient Information; Swelling/ Edema

  MAUDE report 18156173 ↗
• InjuryMay 13, 2022Degraded; Degraded

  IT WAS REPORTED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19 MM 3000 AORTIC VALVE IMPLANTED IN THE MITRAL POSITION FOR 4 YEARS AND 2 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO DETERIORATION. THE PROCEDURE WAS PERFORMED WITH A 23 MM 9750TFX TRANSCATHETER VALVE WITH NO COMPLICATIONS. AT THE END OF THE PROCEDURE THE PATIENT WAS HEMODYNAMICALLY STABLE AND WAS TRANSFERRED TO THE CVICU. POST PROCEDURE PATIENT IN RECOVERY. PATIENT WAS DISCHARGE ON POD#1. 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 14402586 ↗
• InjuryMar 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A 19MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF THREE (3) YEARS, ONE (1) MONTH DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 3300TFX AORTIC VALVE. THE PATIENT WAS REPORTED TO BE IN RECOVERY POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11517112 ↗