CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC 2700 (REF 270021MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00690103021592), received between Feb 11, 2021 and Oct 15, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

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

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 21MM 2700 PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A AORTIC VALVED CONDUIT. 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 23285918 ↗
• InjuryMay 5, 2025Degraded; Degraded

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO DEGENERATION AND SEVERE 4+ TRANSVALVULAR AORTIC INSUFFICIENCY. THE PATIENT PRESENTED WITH ACUTE ON CHRONIC DIASTOLIC CONGESTIVE HEART FAILURE NYHA IV. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM NON-EDWARDS DEVICE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE CVICU IN STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21964261 ↗
• InjuryJan 13, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. PROCEDURE WENT AS PLANNED AND PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Insufficient Information

  MAUDE report 21143791 ↗
• InjuryAug 21, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A 21MM 2700 AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO REGURGITATION. PATIENT PRESENTED WITH SHORTNESS OF BREATH. TAVR WAS COMPLETED WITH A 23MM 9755RSL TRANSCATHETER VALVE AND WAS IN STABLE CONDITION AT THE END OF THE PROCEDURE. PER PHYSICIAN THERE WAS NO ALLEGATION OF EDWARDS DEVICE MALFUNCTION OR PREMATURE FAILURE.

  Patient problems: Dyspnea

  MAUDE report 20022003 ↗
• InjuryMay 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2700 VALVE, IMPLANTED IN AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS AND 8 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 23MM 9750TFX.

  Patient problems: Insufficient Information

  MAUDE report 19354162 ↗
• InjuryJun 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 11 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 19MM 11500A VALVE. THE PATIENT WAS IN RECOVERY POST-OPERATION. 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 17159807 ↗
• InjuryJun 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 21MM AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. THE IMPLANTED VALVE WAS REPLACED WITH A 27MM VALVED CONDUIT. 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 17141342 ↗
• InjuryJun 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 2700 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 1 MONTH DUE TO AORTIC REGURGITATION. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION POST PROCEDURE AND WAS DISCHARGED ON POD #4.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 17101005 ↗
• InjuryNov 24, 2021Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2700 AORTIC VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 15 YEARS, 6 MONTHS DUE TO SEVERE STENOSIS. PATIENT PRESENTED WITH DYSPNEA AND SHORTNESS OF BREATH WITH ACUTE, DIASTOLIC HEART FAILURE NYHA CLASS IV. THE TAVR WAS PERFORMED SUCCESSFULLY WITH A 23MM 9750TFX TRANSCATHETER VALVE WITH NO COMPLICATIONS. PATIENT STABLE TO CVICU IN SINUS RHYTHM FOR FURTHER MANAGEMENT. ACCORDING TO THE PHYSICIAN, THERE WAS NO ALLEGATION THAT THE SURGICAL VALVE PREMATURELY FAILED.

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

  MAUDE report 12868768 ↗
• InjuryNov 14, 2021Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 21MM PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 14 YEARS, 10 MONTHS DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A 23MM TRANSCATHETER VALVE. THERE IS NO INVESTIGATIONAL EVIDENCE SUGGESTING THE SURGICAL VALVE FAILED PREMATURELY.

  Patient problems: Insufficient Information

  MAUDE report 12808481 ↗
• InjuryFeb 11, 2021Calcified; Gradient Increase; Patient Device Interaction Problem; Calcified; Gradient Increase; Patient Device Interaction Problem

  THROUGH IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A 21MM 2700 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, 10 MONTHS DUE TO SEVERE RECURRENT AORTIC STENOSIS, SEVERE CALCIFICATION, AND PANNUS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 2700TFX AORTIC VALVE. THE IMPLANTATION DATA CARD INDICATED THAT THE DEVICE EXPLANT WAS NOT DUE TO DEFICIENCY OF THE ORIGINAL DEVICE. PER THE MEDICAL RECORDS, THE PATIENT HAD PROGRESSIVE WORSENING SHORTNESS OF BREATH, FATIGUE SYMPTOMS. OF NOTE, THE PATIENT HAD A VERY LOW LEFT MAIN CORONARY HEIGHT. UPON INSPECTION OF THE AORTIC VALVE DURING REDO SURGERY, THERE WAS SEVERE CALCIFICATION OF ONE OF THE LEAFLETS WITH FIBROUS OVERGROWTH OVER ONE OF THE NON-CORONARY STRUT. THE ANNULUS WAS DEBRIDED. THE LEFT MAIN WAS IDENTIFIED AND IT WAS VERY CLOSE TO THE ANNULUS. THE RIGHT MAIN, HOWEVER, COULD NOT BE IDENTIFIED. INITIALLY, THE SURGEON WANTED TO PLACE A LARGER VALVE; HOWEVER, DUE TO NOT BEING ABLE TO PROPERLY IDENTIFY THE RIGHT CORONARY OSTIUM, HE WAS CONCERNED ABOUT INTRUDING ON IT WITH A LARGER VALVE. THEREFORE, THE DECISION WAS MADE TO SIZE BACK TO A 21MM VALVE. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 2700TFX VALVE. EC

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11318577 ↗