CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFX (REF 3300TFX29MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00690103176179), received between Apr 9, 2021 and Mar 31, 2026 — classified as 97 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (54 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 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 4 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A 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 24749537 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF (B)(6) DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11500A INSPIRIS RESILIA AORTIC VALVE. PATIENT WAS DISCHARGED ON POD#7.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24405845 ↗
• InjuryJan 15, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 3300TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 29MM 11500A INSPIRIS RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 9 YEARS, 4 MONTHS. REASON FOR REINTERVENTION WAS NOT PROVIDED. REPORTEDLY, THE PATIENT WAS IN RECOVERY POST-OPERATIVE. 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 24089282 ↗
• InjuryJan 9, 2026Perivalvular Leak; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 3 MONTHS DUE TO SEVERE PVL. PATIENT PRESENTED WITH SOB AND FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11500A INSPIRIS RESILIA AORTIC VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED FOR REDO AVR AND MV REPAIR. INTRAOPERATIVELY, THE AORTIC VALVE WAS EXAMINED AND NO EVIDENCE OF VALVE LEAFLET ABNORMALITIES WAS FOUND. HOWEVER, THE SURGEON DID NOTICE A LARGE PVL BENEATH THE LEFT/RIGHT COMMISSURE. THE NATIVE MITRAL VALVE WAS REPAIRED UTILIZING A 32MM EDWARDS MC3 ANNULOPLASTY RING. THE AORTIC VALVE WAS THEN SIZED TO A 29MM INSPIRIS RESILIA AORTIC VALVE. THE VALVE WAS SEATED AND SECURED. THE PATIENT WAS WEANED FROM BYPASS WITHOUT DIFFICULTY. POST BYPASS TEE SHOWED NORMALLY FUNCTIONING AORTIC VALVE WITH NO PVL. THE PATHOLOGY REPORT DID NOT REVEAL ANY LEAFLET ISSUES ON THE EXPLANTED 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-MARKE

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 24030636 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 8 MONTHS DUE TO THROMBUS AND AORTIC ROOT ANEURYSM. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT REDO-AVR WITH A 27MM 11060A VALVE AND PFO CLOSURE. PRIOR AORTIC VALVE PROSTHESIS NOTED TO HAVE SIGNIFICANT BURDEN OF PERIPROSTHETIC THROMBUS BUT NO CLEAR SIGNS OF INFECTION, AND WAS DEBRIDED. POST-BYPASS TEE DEMONSTRATED PRESERVED NORMALLY FUNCTIONING AORTIC VALVE BIOPROSTHESIS. THE PATIENT WAS TRANSFERRED TO THE CARDIAC ICU IN CRITICAL BUT STABLE CONDITION. 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 PAT

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23855369 ↗
• InjuryNov 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 3300TFX 29MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 27MM AFTER AN IMPLANT DURATION OF 1 YEAR, 2 MONTHS DUE TO ENDOCARDITIS. PER MEDICAL RECORDS THE REPLACEMENT VALVE HAD EXCELLENT SEATING AND GOOD CLEARANCE OF THE CORONARY OSTIA. THE PATIENT WENT TO THE ICU IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 23633338 ↗
• InjuryNov 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 7 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11060A 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 23589475 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THOUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A VALVE. PER PATHOLOGY REPORT ((B)(6) 2025): CLINICAL INFORMATION SHOWED UNSPECIFIED ENDOCARDITIS AND TYPE. DIAGNOSIS SHOWED PROSTHETIC VALVE MATERIAL WITH ACUTE INFLAMMATION, CONSISTENT WITH ENDOCARDITIS.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 23589186 ↗
• InjuryNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 29MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 6 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 3300TFX VALVE. THE PATIENT WAS REPORTED TO BE IN RECOVERY. 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 23513650 ↗
• InjuryOct 17, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATED THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE IN THE PULMONARY POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO DEGENERATION AND STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH.THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23330768 ↗
• InjurySep 19, 2025Thickening of Material; Thickening of Material

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 7 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH SYMPTOM OF ACUTE HEART FAILURE. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, TTE ON 5/15/2025, VALVE IS THICKENED AND RESTRICTED TO LEAFLET MOTION, WITH MODERATE TO SEVERE STENOSIS

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23102323 ↗
• InjuryAug 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 3300TFX 29MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 5 MONTHS DUE TO UNKNOWN REASONS. A 9755RSL 26MM TRANSCATHETER VALVE WAS IMPLANTED. 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 22884989 ↗
• InjuryAug 22, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 3300TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 29MM 11500A RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO UNKNOWN REASON. REPORTEDLY, PATIENT WAS IN RECOVERY POST-OPERATIVE. 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; Insufficient Information

  MAUDE report 22880086 ↗
• InjuryAug 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN UNKNOWN AORTIC VALVE WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO UNKNOWN REASON. TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22827070 ↗
• InjuryAug 13, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 5 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22797654 ↗
• InjuryAug 13, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 6 MONTHS DUE TO CALCIFICATION, DEGENERATION, INCREASED GRADIENT, AND SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, DYSPNEA AND FATIGUE. THE TAVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Cardiogenic Shock; Heart Failure/Congestive Heart Failure

  MAUDE report 22796824 ↗
• InjuryAug 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS AND EIGHT (8) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22758759 ↗
• InjuryAug 5, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO CALCIFICATION. THE PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, AND DYSPNEA ON EXERTION. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS RESILIA AORTIC VALVE. THE PATIENT WAS STABLE POST-PROCEDURE AND WAS DISCHARGED ON POD #7. 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

  MAUDE report 22719039 ↗
• InjuryJul 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 11 MONTHS DUE TO SEVERE STENOSIS. PATIENT PRESENTED WITH NYHA III HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS TRANSFERRED TO PACU AND WAS DISCHARGED ON POD#0. THIS IS A 67-YEAR-OLD MALE PATIENT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22628804 ↗
• InjuryJun 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 3300TFX AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO UNKNOWN REASONS. TAVR WAS COMPLETED WITH A 29MM 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 22357647 ↗
• InjuryJun 27, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22343223 ↗
• InjuryJun 22, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS DUE TO CALCIFICATION WITH MODERATE TO SEVERE REGURGITATION WITH MODERATE STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS RESILIA AORTIC VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSPORTED TO OPEN HEART RECOVERY UNIT IN STABLE CONDITION. PER PATHOLOGY, EXPLANTED AORTIC VALVE HAD DEGENERATIVE CHANGES WITH DENSELY CALCIFIED BRIGHT YELLOW DEPOSITS. THIS IS A 62-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 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'

  Patient problems: Insufficient Information

  MAUDE report 22304451 ↗
• InjuryJun 9, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 5 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 3300TFX AORTIC VALVE. THE PATIENT WAS IN 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 22168063 ↗
• InjuryJun 2, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND LOWER LEG EDEMA/SWELLING. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9600TFX VALVE. THE PATIENT LEFT THE ROOM IN STABLE CONDITION AND DISCHARGED ON POD # 1.

  Patient problems: Dyspnea; Peripheral Edema

  MAUDE report 22128103 ↗
• InjuryMay 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 1 MONTH DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX 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 22115646 ↗