CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700 (REF 270023MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00690103021608), received between Mar 3, 2021 and Sep 11, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, 11 MONTHS DUE TO INSUFFICIENCY. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE WITH EXCELLENT OUTCOME AND PATIENT WAS IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 23029266 ↗
• InjuryAug 18, 2025Degraded; Degraded

  IT WAS REPORTED THAT A PATIENT WITH A 23 MM 2700 AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 9 MONTHS DUE TO SEVERE REGURGITATION, STENOSIS AND DEGENERATION. THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. THE TPVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 22827902 ↗
• InjuryJun 3, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 7 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH DYSPNEA. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11500A AORTIC VALVE. THE PATIENT EXPIRED ON POD # 12.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22132918 ↗
• InjuryApr 22, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 23MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE IMPLANTATION DATA CARD INDICATED THAT THE PATIENT WAS TAKEN TO 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: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 21883558 ↗
• InjuryMar 11, 2025Degraded; Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 8 MONTHS DUE TO DEGENERATION AND STENOSIS. THE PATIENT PRESENTED WITH CHEST PAIN AND INCREASING FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #4. 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; Fatigue

  MAUDE report 21572860 ↗
• InjuryFeb 13, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2700 AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER IMPLANT DURATION OF NINE (9) YEARS, SEVEN (7) MONTHS DUE TO AORTIC STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS SUCCESSFULLY PERFORMED WITH 23MM 9750TFX VALVE WITHOUT COMPLICATIONS AND PATIENT LEFT THE OR WITH STABLE VITALS.

  Patient problems: Dyspnea

  MAUDE report 21378877 ↗
• InjuryJan 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2700 PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER 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 21192993 ↗
• InjuryNov 11, 2024Fluid/Blood Leak; Device Stenosis; Fluid/Blood Leak; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, ELEVEN (11) MONTHS DUE TO SEVERE AORTIC STENOSIS AND AORTIC REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9755RLS VALVE WITHOUT COMPLICATED. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS.

  Patient problems: Dyspnea

  MAUDE report 20653308 ↗
• InjuryApr 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 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 19068061 ↗
• InjuryApr 2, 2024Gradient 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 IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2700 AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 19021512 ↗
• InjuryDec 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A PATIENT WITH A 23MM 2700 VALVE IN THE PULMONARY POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 7 MONTHS DUE TO UNKNOWN REASON. THE TPVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 18387144 ↗
• InjuryJun 16, 2023Degraded; Insufficient Device Problem Information; Intravalvular regurgitation; Degraded; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 11 MONTHS DUE TO DEGENERATIVE VALVE WITH SEVERE AORTIC INSUFFICIENCY. THE PATIENT PRESENTED WITH SOB, AND CHRONIC DIASTOLIC HEART FAILURE, NYHA CLASS III-IV. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 23MM 9750TFX TRANSCATHETER VALVE WITH NO IMMEDIATE COMPLICATIONS. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE. THE PATIENT WAS DISCHARGE TO HOME ON POD#1.

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

  MAUDE report 17148518 ↗
• InjuryJan 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2700 PERICARDIAL AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, 11 MONTHS DUE TO AORTIC REGURGITATION. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL AND LEFT THE OR IN STABLE CONDITION. PER THE PHYSICIAN, THE VALVE DID NOT FAIL BUT INSTEAD SUCCUMBED TO THE DISEASE PROCESS.

  Patient problems: Insufficient Information

  MAUDE report 13155352 ↗
• InjuryMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THROUGH THE MEDICAL RECORDS, EDWARDS LEARNED THAT A PATIENT DEVELOPED SEVERE MITRAL REGURGITATION AFTER THE IMPLANTATION OF THE 23MM 2700 AORTIC VALVE AND UNDERWENT AN UNPLANNED MITRAL VALVE REPAIR WITH A 26MM COSGROVE BAND. THE PATIENT HAD A HISTORY OF BICUSPID AORTIC VALVE S/P REPAIR AT AGE 5, AND A-FIB. HE PRESENTED WITH SEVERE AS, DILATED AORTIC ROOT WITH CAD APPROXIMATELY 40 YEARS LATER. THE PATIENT UNDERWENT A BENTALL PROCEDURE WITH A 28MM HEMASHIELD GRAFT AND AVR WITH A 23MM 2700 VALVE, CABG, AND COX-MAZE PROCEDURE. THE PROCEDURE WAS COMPLICATED WITH POSTOPERATIVE SEVERE MITRAL REGURGITATION, SO HE WAS PLACED BACK ON BYPASS, AND A MITRAL VALVE REPAIR WAS PERFORMED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11405786 ↗