CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000TFX (REF 3000TFX21MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00690103163643), received between Mar 16, 2021 and Feb 3, 2026 — classified as 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 7 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11500A INSPIRIS 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: Dyspnea; Fatigue; Insufficient Information

  MAUDE report 24248953 ↗
• InjuryJul 24, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22587085 ↗
• InjuryJul 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX 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 22560067 ↗
• InjuryJul 17, 2025Calcified; Calcified

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE IS UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 6 MONTHS DUE TO SEVERE CALCIFIC STENOSIS. PATIENT PRESENTED WITH HEART FAILURE EXACERBATION. THE PROCEDURE IS PERFORMED WITH 23MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22532691 ↗
• InjuryJun 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 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: Insufficient Information

  MAUDE report 22361002 ↗
• InjuryJun 16, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE IS UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS AND THREE (3) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, DYSPNEA, CHEST PAIN, AND SYNCOPE.

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

  MAUDE report 22216081 ↗
• InjuryMay 27, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, TWO (2) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYNCOPE. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND WAS DISCHARGED ON POD #2.

  Patient problems: Dyspnea; Syncope/Fainting

  MAUDE report 22092446 ↗
• InjuryFeb 10, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 21MM 3000TFX AORTIC VALVE IMPLANTED NINE (9) YEARS, NINE (9) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO AORTIC STENOSIS. TAVR WAS SUCCESSFULLY PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 21349787 ↗
• InjuryJan 14, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE, UNDERWENT VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, FIVE (5) MONTHS DUE TO SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE AND SHORTNESS OF BREATH. THE TAVR WAS PERFORMED WITH A 20MM 9750TFX VALVE. THE PATIENT WAS STABLE POST-PROCEDURAL AND WAS DISCHARGED ON POD #8.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21149356 ↗
• InjuryJan 9, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 21MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FOUR (4) MONTHS DUE TO CALCIFICATION. THE EXPLANTED DEVICE WAS REPLACED WITH A 21MM 11500A AORTIC VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PER PATHOLOGY REPORT, EXPLANTED AORTIC VALVE NOTED TO HAVE TAN YELLOW FOCALLY CALCIFIED APPARENT MATERIAL WITH MINIMAL AMOUNT OF ATTACHED PINK-WHITE FIBRO MEMBRANOUS SOFT TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21114506 ↗
• InjuryJan 6, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX 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: Dyspnea; Insufficient Information

  MAUDE report 21079174 ↗
• InjuryNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, TEN MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 8300AB 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 20685714 ↗
• InjuryNov 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 3000TFX 21MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 3300TFX 27MM AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. 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 20674146 ↗
• InjuryAug 21, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LATER LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SOB AND CHEST PAIN. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 20015567 ↗
• InjuryAug 5, 2024Calcified; Patient Device Interaction Problem; Calcified; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 21MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, ONE (1) MONTH DUE TO CALCIFICATION AND PANNUS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A VALVE. PATIENT WAS TAKEN TO THE ICU 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: Dyspnea

  MAUDE report 19906390 ↗
• InjuryJul 16, 2024Degraded; Inadequacy of Device Shape and/or Size; Degraded; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED A PATIENT WITH A 21MM 3000TFX AORTIC VALVE IMPLANTED EIGHT (8) YEARS, SEVEN (7) MONTHS, IS BEING EVALUATED FOR VALVE-IN-VALVE PROCEDURE DUE TO DEGENERATION, STENOSIS, AND PATIENT PROSTHESIS MISMATCH. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. PHYSICIAN TEAM IN DISCUSSION WHETHER TO PROCEED WITH TAVR AND SAVR.

  Patient problems: Dyspnea

  MAUDE report 19756768 ↗
• InjuryApr 30, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A 21MM 3000TFX AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 7 MONTHS DUE TO SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE SYMPTOMS INCLUDING DYSPNEA, FATIGUE, AND LOWER EXTREMITY EDEMA. TAVR WAS COMPLETED WITH A 23MM 9755RSL TRANSCATHETER VALVE WITHOUT PROCEDURAL COMPLICATIONS. THE PATIENT WAS STABLE AND WAS DISCHARGED ON POD# 3. PER MEDICAL RECORD, TTE SHOWED EF OF 50%, BIOPROSTHETIC AORTIC VALVE WITH MODERATE TO SEVERE REGURGITATION, MILDLY ELEVATED PULMONARY PRESSURES, MITRAL ANNULAR CALCIFICATION, THICKENING, MILD REGURGITATION AND MILD TRICUSPID VALVE REGURGITATION.

  Patient problems: Dyspnea; Swelling/ Edema

  MAUDE report 19212428 ↗
• InjuryApr 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 21MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 23MM VALVE AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. 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 19146130 ↗
• InjuryApr 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE IS BEING WORKED UP FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF TWO (2) YEARS, THREE (3) MONTHS DUE TO UNKNOWN REASON. NO OTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19127160 ↗
• InjuryApr 4, 2024Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, TWO (2) MONTHS DUE TO SEVERE STENOSIS SECONDARY TO CALCIFICATION AND DEGENERATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A VALVE. THE PATIENT WAS TAKEN TO RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, INTRAOPERATIVELY, BIOPROSTHETIC AORTIC VALVE WAS NOTED TO BE SEVERELY DEGENERATIVE WITH CALCIFICATIONS PRESENT ON THE LEAFLETS. THE VALVE WAS REMOVED AND THE ANNULUS WAS DEBRIDED. THE ANNULUS WAS SIZED TO A 21MM AND A 11500A VALVE WAS IMPLANTED. THE PATIENT WAS STABILIZED AND TAKEN TO THE CVU POST PROCEDURE. PER PATHOLOGY REPORT, TAN, FIBROUS TISSUE WITH PROMINENT CALCIFICATIONS ATTACHED TO PRONGED METALLIC IMPLANT AND FOCAL DYSTROPHIC CALCIFICATION OF THE VALVE LEAFLETS WERE NOTED. 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 D

  Patient problems: Dyspnea

  MAUDE report 19046428 ↗
• InjuryFeb 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3000TFX AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, EIGHT (8) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX 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 18631160 ↗
• InjuryDec 18, 2023Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A 21MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 9 MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH HF, SOB, AND LOWER EXTREMITY EDEMA. A 23MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Swelling/ Edema

  MAUDE report 18344419 ↗
• InjuryDec 14, 2023Gradient Increase; Gradient Increase

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 21MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 19MM VALVE AFTER AN IMPLANT DURATION OF 6 YEARS, 1 MONTH DUE TO STENOSIS. THE PATIENT PRESENTED WITH SOB AND CHEST PAIN. THE PATIENT WAS 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: Chest Pain; Dyspnea

  MAUDE report 18324572 ↗
• InjurySep 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 21MM 3000TFX VALVE IN THE AORTIC POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 2 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 19MM 11500A VALVE.

  Patient problems: Insufficient Information

  MAUDE report 17746049 ↗
• InjuryJun 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS IMPLANT PATIENT REGISTRY RECEIVED INFORMATION A PATIENT WITH A 21MM 3000TFX AORTIC VALVE IMPLANTED THREE (3) YEARS, SIX (6) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. A 23MM 9750TFX TRANSCATHETER VALVE WAS IMPLANTED INSIDE THE 21MM VALVE. PATIENT POST-OPERATIVE STATUS NOTED AS 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 17175719 ↗