CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC 3000 (REF 300021MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00690103162240), received between Feb 25, 2021 and Sep 2, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22948651 ↗
• InjuryAug 8, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS DUE TO SEVERE AORTIC STENOSIS WITH AN ELEVATED GRADIENT OF 30+MMHG. THE PATIENT INITIALLY PRESENTED WITH SHORTNESS OF BREATH. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE WITH NO RESULTING CENTRAL LEAK.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22746614 ↗
• InjuryNov 11, 2024Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED AND INVESTIGATION THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO CALCIFICATION, DEGENERATION, AND STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SOB. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

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

  MAUDE report 20655580 ↗
• InjuryNov 5, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, SIX (6) MONTHS DUE TO CRITICAL AORTIC STENOSIS. THE PATIENT PRESENTED WITH SYSTOLIC HEART FAILURE. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20612525 ↗
• InjuryOct 10, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS AND TEN (10) MONTHS DUE TO STENOTIC LEAFLETS. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PROCEDURE WAS A PLANNED OPEN-HEART PROCEDURE, AND IT WAS SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 20423987 ↗
• InjuryOct 8, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE IS UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 10 MONTHS DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PROCEDURE HAS NOT BEEN SCHEDULED YET. THIS IS A 82-YEAR-OLD FEMALE PATIENT.

  Patient problems: Dyspnea

  MAUDE report 20403251 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 21MM 3000 AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL VALVE. 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: Insufficient Information

  MAUDE report 19538773 ↗
• InjuryJun 4, 2024Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS DUE TO STENOSIS SECONDARY TO CALCIFICATION. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE WITH GREAT RESULT.

  Patient problems: Insufficient Information

  MAUDE report 19461728 ↗
• InjuryJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 21MM 3000 VALVE IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO UNKNOWN REASON. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19454548 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS, IT WAS LEARNED A 21MM 3000 AORTIC VALVE, WAS EXPLANTED AFTER SEVEN (7) YEARS AND NINE (9) MONTHS DUE TO ENDOCARDITIS AND SEVERE STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A AORTIC VALVE. PER MEDICAL RECORDS, DURING THE PROCEDURE PURULENT DRAINAGE WAS VISIBLE FROM THE LEFT EDGE, AROUND THE R/L AND R/NON-CORONARY JUNCTIONS. THE ANNULUS WAS DEBRIDED. AFTER RECTIFYING A DISCOVERED AV GAP AND ANASTOMOSING WITH A LARGE PERICARDIAL PATCH, THE SURGEON SIZED A 25MM 11500A TO BE MOST APPROPRIATE. AFTER THE 25MM 11500A WAS PROPERLY SUTURED IN PLACE, THE PATIENT WAS THEN TRANSITIONED OFF BYPASS. POST-BYPASS TEE SHOWED THE PROSTHESIS WAS WELL-POSITIONED WITH NO PVL. THIS 63-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 CARD

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 19071895 ↗
• InjuryMar 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL 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 18937743 ↗
• InjuryMar 1, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 21MM 3000 AORTIC VALVE IMPLANTED EIGHT (8) YEARS, TWO (2) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO MIXED AORTIC STENOSIS AND INSUFFICIENCY. TAVR WAS SUCCESSFULLY PERFORMED WITH A 20MM S3 ULTRA RESILIA TRANSCATHETER VALVE.

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

  MAUDE report 18822664 ↗
• InjuryAug 1, 2023Fluid/Blood Leak; Gradient Increase; Device Stenosis; Intravalvular regurgitation; Fluid/Blood Leak; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  IT WAS LEARNED THAT A PATIENT WITH A 21MM 3000 VALVE IN THE PULMONARY POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 2 MONTHS DUE TO STENOSIS AND REGURGITATION. THE TPVR WAS PERFORMED WITH A 23MM 9600TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438896 ↗
• InjuryMar 20, 2023Gradient Increase; Gradient Increase

  IT WAS LEARNED VIA THE IMPLANT PATIENT REGISTRY THAT A 21MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED FOR SIX (6) YEARS AND FOUR (4) MONTHS, WAS EXPLANTED DUE TO STENOSIS. THE PATIENT PRESENTED WITH HF, SOB, AND CHEST PAIN. THE EXPLANTED DEVICE WAS REPLACED WITH A 21MM AORTIC VALVED CONDUIT. PER MEDICAL RECORDS THE PREOPERATIVE DIAGNOSIS WAS PROSTHETIC VALVE DYSFUNCTION AND MODERATE NON ISCHEMIC CARDIOMYOPATHY. PREOPERATIVELY THE PATIENT WAS DIAGNOSED DURING WORK UP WITH A STOVE PIPE AORTA. THE PATIENT UNDERWENT CARDIAC DECORTICATION, A MODIFIED BENTALL REDO AVR PROCEDURE USING A 21 MM AORTIC VALVED CONDUIT AND CABG X 1. THE PATIENTS POST OPERATIVE COURSE WAS COMPLICATED BY RESPIRATORY FAILURE, AKI AND SUSPECTED HIT. THE PATIENTS CONTINUED TO DETERIORATE AND THE PATIENT WAS TRANSITIONED TO COMFORT CARE. THE PATIENT EXPIRED ON POD #15. 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/

  Patient problems: Chest Pain; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 16577063 ↗
• InjuryMar 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 PERICARDIAL AORTIC VALVE WAS PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF THREE (3) YEARS DUE TO UNKNOWN REASONS. THE PATIENT PASSED AWAY DUE TO UNKNOWN REASONS BEFORE UNDERGOING THE TAVR PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 13920633 ↗
• InjuryNov 13, 2021Degraded; Fluid/Blood Leak; Degraded; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 13 YEARS, 26 DAYS DUE TO INSUFFICIENCY, LEAFLET MALFUNCTION, AND DEGENERATION. PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE (NYHA CLASS 3-4) THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. PATIENT WAS TRANSFERRED TO RECOVERY.

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

  MAUDE report 12808263 ↗
• InjurySep 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH EDWARDS IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 12 YEARS, FOUR (4) MONTHS DUE TO UNKNOWN REASONS. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THERE WAS NO INVESTIGATIONAL EVIDENCE OF A PREMATURE FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 12455164 ↗
• InjuryAug 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH EDWARDS IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 15 YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THERE IS NO INVESTIGATIONAL EVIDENCE TO SUGGEST THAT THE DISABLED SURGICAL VALVE HAD PREMATURELY FAILED.

  Patient problems: Insufficient Information

  MAUDE report 12350264 ↗
• InjuryFeb 25, 2021Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC PERICARDIAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, SIX (6) MONTHS DUE TO SEVERE AORTIC STENOSIS. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE SUCCESSFULLY. THE PRE-EXISTING SURGICAL RING WAS FRACTURED WITH A TRUE BALLOON AND THE NEWLY IMPLANTED VALVE WAS EXPANDED COMPLETELY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE ICU. THE PATIENT WAS DISCHARGED HOME ON POD #2 IN STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11380877 ↗