CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC 3000 (REF 300027MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00690103162271), received between Sep 15, 2021 and Aug 4, 2025 — classified as 15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED THROUGH SMART START THAT A PATIENT WITH A 27MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO CALCIFICATION. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

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

  MAUDE report 22699307 ↗
• InjuryMay 29, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 8 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #5.

  Patient problems: Dyspnea

  MAUDE report 22111485 ↗
• InjuryApr 2, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS, THAT A 27MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FOUR (4) MONTHS DUE TO CALCIFIC DEGENERATION AND SEVERE STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A NON-EDWARDS MECHANICAL VALVE. PATIENT WAS TAKEN TO RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH DYSPNEA ON EXERTION AND INCREASE FATIGUE. PRE- OP IMAGING DEMONSTRATE ENLARGING SINUS OF VALSALVA ANEURYSM WITH STRUCTURAL VALVE DETERIORATION OF THE BIOPROSTHETIC AORTIC VALVE WITH SEVERE AS AND REDUCED EF AT 52%. THE PATIENT UNDERWENT A REDO STERNOTOMY IN WHICH THE 27MM 3000 MAGNA EASE WAS EXPLANTED AND REPLACED WITH NON-EDWARDS MECHANICAL VALVE. CONCOMITANTLY, THE PATENT UNDERWENT TRICUSPID VALVE REPAIR USING 32MM 6200 PHYSIO RING. UPON WEANING FROM BYPASS, THE PATIENT WAS PROFOUNDLY VASOPLEGIC WITH MINIMAL RESPONSE TO VASOCONSTRICTORS. VA ECMO CIRCUIT WAS PLACED WITHOUT ISSUE AND THE PATIENT WAS TRANSFERRED TO CVICU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM HOSPITAL POD # 13. PER PATHOLOGY REPORT, FRAGMENTS OF FIBROCONNECTIVE TISSUE WITH DYSTROPHIC CALCIFICATIONS, NECROSIS, ACUTE IN

  Patient problems: Dyspnea; Fatigue

  MAUDE report 21756636 ↗
• InjuryJan 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 3000 AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, EIGHT (8) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 3300TFX 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 21096633 ↗
• InjuryNov 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MODEL 3000 27MM PERICARDIAL VALVE IN PULMONARY POSITION WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. A 9600TFX 29MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20735865 ↗
• InjuryApr 17, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 27MM 3000 AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 1 MONTH DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE, AND PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 19128717 ↗
• InjuryApr 16, 2024Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT PATIENT WITH A 27MM 3000 AORTIC VALVE UNDERWENT VALVE-IN-VALVE PROCEDURE AFTER IMPLANT DURATION OF FIVE (5) YEARS, THREE (3) MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH 26MM 9755RSL TRANSCATHETER VALVE. THE CASE WENT PERFECT AND THE PATIENT IS DOING WELL IN RECOVERY.

  Patient problems: Cardiogenic Shock; Dyspnea; Insufficient Information

  MAUDE report 19120482 ↗
• InjuryFeb 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 27MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, EIGHT (8) MONTHS, DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 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 18633737 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intravalvular regurgitation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 27MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO MILD REGURGITATION, TYPE A AORTIC ROOT DISSECTION AND AORTIC ROOT PSEUDOANEURYSM. THE PATIENT PRESENTED WITH SOB AND AFIB. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A AORTIC VALVED CONDUIT. PER MEDICAL RECORDS ,THE PATIENT PRESENTED WITH TYPE A DISSECTION OF THE DISTAL AORTIC ARCH AND DESCENDING AORTA AND PSEUDOANEURYSM OF THE AORTIC ROOT, ALONG WITH ATRIAL DYSRHYTHMIA. THE PATIENT UNDERWENT REDO STERNOTOMY, AVR VIA BIOBENTALL PROCEDURE, HYBRID TOTAL ARCH REPLACEMENT, AND LEFT ATRIAL APPENDAGE CLIP. INTRAOPERATIVELY, IT IS NOTED THAT THE RIGHT SUBCLAVIAN TO FEMORAL BYPASS WAS THROMBOSED. THE AORTIC VALVE, AORTIC ROOT , AND ASCENDING AORTA WERE REMOVED AND A 27MM KONECT AORTIC VALVED CONDUIT WAS IMPLANTED. POST BYPASS TEE SHOWED WELL-SEATED VALVED CONDUIT WITH NO AI NOR PVL. THE PATIENT TOLERATED PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS AND WAS DISCHARGED ON POD#19. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWAR

  Patient problems: Atrial Fibrillation; Dyspnea; Insufficient Information; Pseudoaneurysm; Vascular Dissection

  MAUDE report 18504109 ↗
• InjuryAug 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3000 PERICARDIAL AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 17627400 ↗
• InjuryAug 11, 2023Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 3000 PERICARDIAL AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, ONE (1) MONTH DUE TO SEVERE, SYMPTOMATIC AORTIC STENOSIS. THE PATIENT WAS ADMITTED WITH HEART FAILURE, SHORTNESS OF BREATH, WITH HYPOXIA AND IN CARDIOGENIC SHOCK. THE TAVR PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS NOTED TO BE IN RECOVERY POST PROCEDURE AND WAS DISCHARGED ON POD #5. PER MEDICAL RECORDS: THE PATIENT WAS BEING EVALUATED FOR ELECTIVE TAVR BUT DECOMPENSATED REQUIRING ADMISSION AND INTUBATION PRIOR TO TAVR.

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

  MAUDE report 17515802 ↗
• InjuryMar 21, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A 27MM AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 11 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HF AND SOB. A 26MM TRANSCATHETER VALVE WAS IMPLANTED. THE PATIENT WAS IN RECOVERY.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 16585182 ↗
• InjuryAug 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 27 MM 3000 VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 6 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25 MM 11500A VALVE. IT WAS ALSO REPORTED THAT THE PATIENT EXPIRED 9 DAYS AFTER THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15179140 ↗
• InjuryDec 22, 2021Gradient Increase; Difficult to Open or Close; Insufficient Device Problem Information; Gradient Increase; Difficult to Open or Close; Insufficient Device Problem Information

  THROUGH THE IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 27 MM 3000 AORTIC VALVE BOTH IMPLANTED FOR 5 YEARS, 1 MONTH UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO REDUCED LEAFLET EXCURSION WITH SEVERE STENOSIS. PATIENT PRESENTED WITH WORSENING FATIGUE AND SOB, AND ACUTE ON CHRONIC SYSTOLIC HEART FAILURE. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX VALVE. PATIENT CONCOMITANTLY ALSO UNDERWENT A TMVR.

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

  MAUDE report 13067208 ↗
• InjurySep 15, 2021Degraded; Gradient Increase; Degraded; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3000 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, EIGHT (8) MONTHS DUE TO SYMPTOMATIC SEVERE STENOSIS (MEAN GRADIENT 44MMHG) AND DEGENERATION. THE PATIENT PRESENTED 29 WEEK PREGNANT WITH PALPITATIONS AND DYSPNEA. A TAVR WAS PERFORMED WITH A 26MM 9750TFX VALVE WITH NO COMPLICATIONS. POST-TAVR ECHOCARDIOGRAM REVEALED A MEAN AORTIC VALVE GRADIENT OF 17 MMHG WITHOUT AI. PATIENT WAS DISCHARGED 24 HOURS POST-PROCEDURE. PER LITERATURE REVIEW OF TAVR BEYOND FETAL VIABILITY AN ALTERNATIVE TO PRETERM DELIVERY IN SYMPTOMATIC SEVERE AORTIC STENOSIS: THIS IS THE FIRST REPORTED TAVR IN 3RD TRIMESTER. POST TAVIV, THE PATIENT UNDERWENT AN UNCOMPLICATE PRIMARY CESAREAN SECTION(BREECH) AT TERM.

  Patient problems: Dyspnea; Insufficient Information; Irregular Pulse

  MAUDE report 12478744 ↗