CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700 (REF 270025MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00690103021615), received between Feb 19, 2021 and Mar 10, 2026 — classified as 1 death, 20 injuries.

The most frequently reported specific device problem is “Gradient Increase” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Calcified

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700 PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, ONE (1) MONTH DUE TO CALCIFICATION. THE PATIENT INITIALLY PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON POD #13. 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

  MAUDE report 24560048 ↗
• InjuryAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700 PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, THREE (3) MONTHS DUE TO AORTIC REGURGITATION. THE PATIENT INITIALLY PRESENTED WITH SHORTNESS OF BREATH. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Dyspnea

  MAUDE report 22798088 ↗
• InjuryAug 8, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 25MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, AND 11 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH DYSPNEA, CHEST PAIN, AND LEG SWELLING. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A AORTIC VALVE. THE PATIENT WAS DISCHARGED POD#5. 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; Swelling/ Edema

  MAUDE report 22760022 ↗
• InjuryMay 12, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700 AORTIC VALVE IN AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, ELEVEN MONTHS DUE TO STENOSIS. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION AND DISCHARGED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 22004018 ↗
• InjuryFeb 4, 2025Degraded; Intravalvular regurgitation; Degraded; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 7 MONTHS DUE TO SVD AND SEVERE REGURGITATION. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A AORTIC VALVED CONDUIT. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. UNDERWENT REDO AVR WITH AORTIC ROOT REPLACEMENT, ASCENDING AORTA REPLACEMENT WITH A 28MM HEMASHIELD GRAFT, CABG X1, MVR WITH NON-EDWARDS 29MM MECHANICAL VALVE, AND ENDARTERECTOMY. THE 23MM 11060 AVC IN THE SUPRA-ANNULAR POSITION WAS SEWN IN WITH INTERRUPTED NON-EVERTING PLEDGETED STITCHES USING THE AORTIC WALL AS REINFORCEMENT. THE PATIENT TOLERATED THE PROCEDURE WELL, WITH NO COMPLICATIONS, AND WAS DISCHARGED ON POD #14. 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 IMPLANT

  Patient problems: Dyspnea

  MAUDE report 21309488 ↗
• InjuryOct 15, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700 PERICARDIAL AORTIC VALVE WAS PLACED UNDER EVALUATION FOR REDO AORTIC VALVE REPLCEMENT AFTER AN IMPLANT DURATION OF SIX (6) YEARS, NINE (9) MONTHS DUE TO SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH CHRONIC EXERTIONAL DYSPNEA.

  Patient problems: Dyspnea

  MAUDE report 20453398 ↗
• InjuryJul 16, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 25MM 2700 AORTIC VALVE IMPLANTED IN PULMONARY POSITION SEVEN (7) YEARS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO PULMONARY STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. TPVR WAS PERFORMED WITH A 26MM 9600TFX TRANSCATHETER VALVE. PATIENT WAS STABLE AT AT THE END OF THE PROCEDURE. THIS IS 17-YEAR-OLD MALE PATIENT.

  Patient problems: Dyspnea

  MAUDE report 19756953 ↗
• InjuryMay 21, 2024Device Stenosis; Device Stenosis

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A PATIENT WITH A 25MM 2700 AORTIC VALVE IMPLANTED SEVEN (7) YEARS, TWO (2) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. TAVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE AT THE END OF THE 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: Dyspnea

  MAUDE report 19367226 ↗
• InjuryMay 17, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700 PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, SIX (6) MONTHS DUE TO SEVERE AORTIC STENOSIS. THE PATIENT HAS PRESENTED WITH CHEST PRESSURE, ANGINA, AND DYSPNEA ON EXERTION. THE TAVR PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Angina; Dyspnea

  MAUDE report 19346627 ↗
• InjuryJan 22, 2024Gradient Increase; Perivalvular Leak; Gradient Increase; Perivalvular Leak

  IT WAS REPORTED THAT PATIENT WITH A 25MM 2700 AORTIC VALVE UNDERWENT VALVE -IN VALVE AFTER IMPLANT DURATION OF 7 YEARS, 7 MONTHS DUE TO PERIVALVULAR LEAK AND STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 18554233 ↗
• InjuryOct 25, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 3 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE CLASS II. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX VALVE AND THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 18007790 ↗
• InjuryOct 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700 PERICARDIAL AORTIC VALVE UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, NINE (9) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 3300TFX PERICARDIAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 17890651 ↗
• InjuryOct 4, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A 25MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO STENOSIS. A 23MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 17871201 ↗
• InjuryAug 30, 2023Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A PATIENT WITH A 25MM 2700 VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 (FIVE) YEARS, 10 MONTHS DUE TO UNKNOWN REASONS. THE TAVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS IN RECOVERY POST PROCEDURE.

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

  MAUDE report 17654891 ↗
• DeathAug 16, 2023Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700 VALVE IN THE AORTIC POSITION IS UNDER EVALUATION FOR VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF 7 YEARS, 6 MONTHS DUE TO STENOSIS. REPLACEMENT VALVE INFORMATION IS UNKNOWN.

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

  MAUDE report 17561523 ↗
• InjuryMay 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 25MM AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTH DUE TO REGURGITATION. THE PATIENT PRESENTED SHORTNESS OF BREATH WITH EXERTION. THE PROCEDURE WAS PERFORMED WITH A 26MM TRANSCATHETER VALVE. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS SENT TO RECOVERY POST-PROCEDURE.

  Patient problems: Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure

  MAUDE report 16977783 ↗
• InjuryApr 26, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT THIS PATIENT WITH A 25MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT YEARS DUE TO SEVERE STENOSIS. THE PATIENT CHIEF COMPLAINT WAS SHORTNESS OF BREATH. TAVR WAS PERFORMED WITH A 9750TFX26A TRANSCATHETER VALVE WITHOUT COMPLICATIONS. THE PATIENT WAS SENT TO RECOVERY WITH NORMAL VITALS AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 16820773 ↗
• InjuryDec 7, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  PER PHYSICIAN, SURGICAL VALVE DID NOT PREMATURELY FAIL.

  Patient problems: Insufficient Information

  MAUDE report 12955758 ↗
• InjuryOct 28, 2021Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 16 YEARS, ONE (1) MONTH DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. ACCORDING TO THE PHYSICIAN, THERE WAS NO ALLEGATION THAT THE SURGICAL VALVE PREMATURELY FAILED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12715840 ↗
• InjuryJul 12, 2021Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 16 YEARS, THREE (3) MONTHS DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. IT WAS REPORTED THAT THE PATIENT IS DOING WELL. AS REPORTED, THE SURGICAL VALVE, PERFORMED AS INTENDED. THE PHYSICIAN DID NOT INDICATE DEVICE FAILURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12155108 ↗
• InjuryFeb 19, 2021Calcified; Degraded; Gradient Increase; Difficult to Open or Close; Calcified; Degraded; Gradient Increase; Difficult to Open or Close

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7), FOUR (4) MONTHS DUE TO CALCIFIC DEGENERATION, SEVERE AORTIC STENOSIS, LEAFLET IMMOBILITY. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE SUCCESSFULLY AND THE PATIENT WAS TAKEN TO THE PACU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED HOME ON POD #3 IN GOOD CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11351047 ↗