CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800 (REF 280025MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00690103021677), received between Feb 8, 2021 and Oct 15, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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.

• InjuryOct 15, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2800 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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: Dyspnea; Insufficient Information

  MAUDE report 23277199 ↗
• InjuryJun 12, 2025Break; Break

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 2800 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS,11 MONTHS DUE TO LEAFLET PERFORATION AND STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS RELISA AORTIC VALVE. PER PATHOLOGY, EXPLANTED AORTIC VALVE CONSISTED OF ONE LEAFLET WITH 4 HOLES. GROSS EXAM DIAGNOSIS: LEAFLET PERFORATION. THIS IS A 64-YEAR-OLD MALE PATIENT. 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: Dizziness; Dyspnea; Insufficient Information

  MAUDE report 22198482 ↗
• InjuryApr 25, 2025Calcified; Patient Device Interaction Problem; Calcified; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 2800 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO CALCIFICATION AND PANNUS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT A REDO AVR WITH ASCENDING AORTOPLASTY, AND MVR WITH 33MM NON-EDWARDS RING. THE AORTIC VALVE WAS REPLACED WITH A 25M INSPIRIS VALVE WITH PLEDGETED NON-EVERTING MATTRESS SUTURES. POST-OP TEE SHOWED NO PVL THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON POD #7. HOSPITAL PATHOLOGY REPORT: AORTIC PROSTHETIC VALVE, GROSS EXAM ONLY. ALL 3 LEAFLETS DEMONSTRATE RESTRICTED MOBILITY DUE TO CALCIFICATION. ON THE ATRIAL SIDE OF THE VALVE ARE MULTIPLE CALCIFICATIONS AND SEVERE PANNUS FORMATION. VEGETATIONS ARE NOT IDENTIFIED.

  Patient problems: Insufficient Information

  MAUDE report 21913513 ↗
• InjuryFeb 21, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2800 PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Fatigue; Insufficient Information

  MAUDE report 21435671 ↗
• InjuryOct 28, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH AN 25MM 2800 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 11 MONTHS DUE TO LEAFLET PERFORATION CAUSING REGURGITATION. THE PATIENT PRESENTED WITH SOB. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION AND TRANSFERRED TO PACU POST PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 20547790 ↗
• InjuryJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2800 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A 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 19798950 ↗
• InjuryJan 30, 2024Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 2800 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 1 MONTH DUE TO CALCIFICATION AND STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE AND WAS DISCHARGED POST PROCEDURE. THIS IS A 39-YEAR-OLD FEMALE PATIENT . 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; Fatigue; Insufficient Information

  MAUDE report 18607550 ↗
• InjuryMay 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED FROM THE IMPLANT PATIENT REGISTRY THAT A MODEL 2800 25MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 23MM VALVE AFTER AN IMPLANT DURATION OF 6 YEARS, 3 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 16919812 ↗
• InjuryNov 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2800 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 16 YEARS, SIX (6) MONTHS DUE TO INSUFFICIENCY. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE WITH NO COMPLICATIONS. ACCORDING TO THE PHYSICIAN, THERE WAS NO ALLEGATION THAT THE SURGICAL VALVE PREMATURELY FAILED.

  Patient problems: Insufficient Information

  MAUDE report 12775691 ↗
• InjuryJul 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH THE EDWARDS IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 25MM 2800 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 13 YEARS, FOUR (4) MONTHS DUE TO UNKNOWN REASON. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. 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 12104368 ↗
• InjuryFeb 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2800 AORTIC VALVE, IMPLANTED IN THE PULMONARY POSITION, UNDERWENT A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF FIVE (5), SIX (6) MONTHS DUE TO REGURGITATION. THE TPVR WAS PERFORMED WITH A 26MM 9600TFX VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 11294272 ↗