CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFX (REF 3000TFX25MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00690103163667), received between Feb 8, 2021 and May 15, 2026 — classified as 51 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 51 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3000TFX MAGNA AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 25MM 11500A INSPIRIS RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS. REASON FOR REINTERVENTION WAS NOT PROVIDED. 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 25191315 ↗
• InjuryNov 21, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY AND LEARNED THROUGH INVESTIGATION THAT A 25MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH LOWER EXTREMITY EDEMA AND TACHYCARDIA. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11500A VALVE. THE PATIENT WAS STABLE POST-PROCEDURE AND WAS 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: Tachycardia

  MAUDE report 23623696 ↗
• InjuryAug 29, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE TAVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22923734 ↗
• InjuryAug 18, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH 25MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22827363 ↗
• InjuryAug 15, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS AND 11 MONTHS DUE TO CALCIFICATION AND MODERATE STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 22814424 ↗
• InjuryAug 14, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 4 MONTHS DUE TO SEVERE AORTIC STENOSIS (MG 44 MMHG). THE PATIENT PRESENTED WITH FATIGUE AND SHORTNESS OF BREATH. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 22806533 ↗
• InjuryAug 12, 2025Degraded; Thickening of Material; Degraded; Thickening of Material

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 7 MONTHS DUE TO THICKEN LEAFLETS WITH SEVERE STENOSIS. THE PATIENT PRESENTED WITH FATIGUE AND VENTRICULAR TACHYCARDIA. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE. PRE-OP ECHO: THE LEAFLETS ARE NOT WELL VISUALIZED, BUT THEY ARE THICKENED. VMAX OF 4.2 M/S, MEAN PG 48 MMHG, DVI 0.21, AT 110 MSEC. THERE IS SEVERE PROSTHETIC VALVE STENOSIS PRESENT.

  Patient problems: Fatigue

  MAUDE report 22784167 ↗
• InjuryJun 23, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 1 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 26MM 9755RSL TRANSCATHETER VALVE.

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

  MAUDE report 22312115 ↗
• InjuryJun 16, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS AND FOUR (4) MONTHS DUE STENOSIS. THE PATIENT PRESENTED WITH DYSPNEA AND ACUTE CARDIOGENIC SHOCK. THE PROCEDURE WAS PERFORMED WITH 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Cardiogenic Shock; Dyspnea

  MAUDE report 22216102 ↗
• InjuryJun 16, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND PROGRESSIVE FATIGUE. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE AND DISCHARGED ON POD #1.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 22214099 ↗
• InjuryMay 29, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE IN PULMONARY POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 7 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH FATIGUE AND FREQUENT RUNS OF SVT AND NSVT. THE TPVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #1.

  Patient problems: Arrhythmia; Dyspnea

  MAUDE report 22111646 ↗
• InjuryApr 22, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, TEN MONTHS DUE TO CALCIFICATION AND REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A AORTIC VALVE. THE PATIENT WAS STABLE 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

  MAUDE report 21886191 ↗
• InjuryApr 14, 2025Calcified; Calcified

  IT WAS REPORTED AND PER INVESTIGATION THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION/CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS AND 7 MONTHS, DUE TO CALCIFICATION WITH STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, CHEST PAIN AND FATIGUE.

  Patient problems: Chest Pain; Dyspnea; Fatigue; Insufficient Information

  MAUDE report 21837045 ↗
• InjuryFeb 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT 25 MM 3000TFX AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 10 MONTHS DUE TO UNKNOWN REASONS. TAVR WAS PERFORMED WITH A 26 MM 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 21307608 ↗
• InjuryDec 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 25MM 3000TFX AORTIC VALVE IMPLANTED THREE (3) YEARS, TWO (2) MONTHS, WAS EXPLANTED DUE TO MSSA ENDOCARDITIS. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11060A AORTIC VALVED CONDUIT. THE PATIENT ALSO UNDERWENT MITRAL VALVE REPLACEMENT WITH A 29MM 11400M MITRAL VALVE DURING THE OPERATION. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO ICU IN STABLE CONDITION. PER MEDICAL RECORDS, PATIENT PRESENTED A HEADACHE FOLLOWED BY FEVER, CONFUSION, AND DIAPHORESIS. PREOPERATIVE TEE FOUND THAT THERE IS SEVERE THICKENING OF THE LEFT CORONARY CUSP, RIGHT CORONARY CUSP AND NONCORONARY CUSP OF THE AORTIC VALVE. PATIENT TREATED WITH IV ANTIBIOTICS. BLOOD CULTURES GREW MSSA. RECENT EMBOLIC CVA WITH BLEEDING AND WAS LEFT WITH SIGNIFICANT ISCHEMIC CHANGES/NECROSIS THAT WILL NECESSITATE AMPUTATION OF AREAS OF THE 4 EXTREMITIES. TEE DEMONSTRATED THE BIOPROSTHETIC AORTIC VALVE IS EXTREMELY INFECTED AND HAS LARGE AND HIGHLY MOBILE VEGETATIONS ATTACHED TO THE AORTIC AND VENTRICULAR ASPECTS OF THE PROSTHESIS WITH A SMALL PVL NOTED ALONG THE LATERAL ASPECT OF THE PROSTHESIS (3:00 IN THE SHORT AXIS PLANE). THE PATIENT UNDERWE

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 20887198 ↗
• InjuryNov 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3000TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, EIGHT (8) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11500A INSPIRIS 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 20668748 ↗
• InjuryNov 11, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, SIX (6) MONTHS DUE TO AORTIC STENOSIS. THE PATIENT HAS PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS VALVE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 20653697 ↗
• InjuryOct 14, 2024Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3000TFX AORTIC VALVE, IMPLANTED IN THE AORTIC POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) YEARS AND SIX (6) MONTHS DUE TO STENOSIS AND CALCIFICATION. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11500A AORTIC VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE AND DISCHARGED ON POD #5.

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

  MAUDE report 20446568 ↗
• InjuryAug 5, 2024Adverse 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 THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS,10 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A 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: Endocarditis; Insufficient Information

  MAUDE report 19910821 ↗
• InjuryJul 17, 2024Device Stenosis; Device Stenosis

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 3000TFX 25MM VALVE IN PULMONARY POSITION WAS EXPLANTED AND REPLACED WITH A 11500A 29MM AFTER AN IMPLANT DURATION OF 4 YEARS, 11 MONTHS DUE TO STENOSIS WITH SEVERE SUBVALVULAR STENOSIS. PER MEDICAL RECORDS THE PATIENT PRESENTED WITH PROGRESSIVE EXERTIONAL DYSPNEA. HEART CATH SHOWED STENOTIC PULMONIC VALVE. SHE UNDERWENT REDO-PVR WITH RVOT RECONSTRUCTION WITH BOVINE PERICARDIUM, AND CABG X1. THE PREVIOUS DACRON GRAFT HAD SEVERE SUBVALVULAR STENOSIS, IT WAS OPEN AND THE 25MM VALVE CAME OUT PRETTY EASILY. THE GRAFT WAS CLEANED OF PANNUS AND FIBROUS TISSUE. A 29MM 11500A WAS THEN SEWN INTO THE PREVIOUS GRAFT. AFTER WEANING OFF CPB, THERE WAS GOOD PROSTHETIC VALVE FUNCTION AND BIVENTRICULAR FUNCTION, AND SHE WAS TRANSFERRED TO THE ICU. ON POD 5, THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON ASPIRIN AND COUMADIN (FOR MECHANICAL AVR). 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

  Patient problems: Dyspnea

  MAUDE report 19758032 ↗
• InjuryMay 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3300TFX PERICARDIAL AORTIC VALVE UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, EIGHT (8) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 25MM 3300TFX PERICARDIAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19346499 ↗
• InjuryMay 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A 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 19263149 ↗
• InjuryApr 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000TFX VALVE, IMPLANTED IN AORTIC POSITION, IS UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AND IMPLANT DURATION OF 6 YEARS AND 9 MONTHS DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 19196302 ↗
• InjuryApr 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL 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 19073126 ↗
• InjuryMar 28, 2024Degraded; Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO DEGENERATION AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE AND SYNCOPE. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGED POD #3. 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; Syncope/Fainting

  MAUDE report 18994919 ↗