CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFX (REF 3300TFX27MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 00690103176162), received between Feb 1, 2021 and Sep 11, 2026 — classified as 260 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (135 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 260 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50739915 ↗
• InjuryMay 29, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27 MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 7 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27 MM 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 25335574 ↗
• InjuryMar 20, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 3300TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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 24651234 ↗
• InjuryFeb 26, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) YEARS, AND 11 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 3300TFX AORTIC 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 24464016 ↗
• InjuryFeb 2, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 3300TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF TWO (2) YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 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 24229244 ↗
• InjuryJan 16, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 3300TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, THREE (3) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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 24098309 ↗
• InjuryDec 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27 MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 10 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25 MM 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 23917272 ↗
• InjuryDec 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 3300TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, EIGHT (8) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE 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 23854598 ↗
• InjuryDec 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 10 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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 23831973 ↗
• InjuryDec 2, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #5. 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 23700934 ↗
• InjuryNov 10, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 4 MONTHS DUE TO AORTIC STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. DURING THE TAVR PROCEDURE THERE WAS DIFFICULTY CROSSING THE ANNULUS, PATIENT WENT INTO ASYSTOLE AND ALL DEVICES WERE REMOVED. THEN ANOTHER 26MM 9755RSL VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE AND SENT TO RECOVERY POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23510867 ↗
• InjurySep 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY (IPR). 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. PER THE REPORT RECEIVED FROM CANADA VIA IMPLANT PATIENT REGISTRY (IPR), THIS VALVE MODEL 3300TFX27MM WAS EXPLANTED FROM THE AORTIC POSITION AFTER AN IMPLANT DURATION OF THREE (3) YEARS AND 3 MONTHS DUE TO UNKNOWN REASONS. A 25MM BIOPROSTHETIC VALVE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23164754 ↗
• InjurySep 19, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED AND THROUGH INVESTIGATION THAT A PATIENT WITH A 27MM 3300TFX AORTIC VALVE IMPLANTED IN THE PULMONIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO MODERATE INSUFFICIENCY AND MILD-MODERATE STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND WAS DISCHARGED ON POD#1.

  Patient problems: Dyspnea

  MAUDE report 23100231 ↗
• InjurySep 19, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3300TFX VALVE, IMPLANTED IN PULMONARY POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS DUE TO REGURGITATION AND STENOSIS. THE PATIENT WAS PRESENTED WITH DYSPNEA AND FATIGUE. THE VALVE WAS REPLACED WITH A 29MM 9600TFX TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 23097118 ↗
• InjurySep 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 27MM 3300TFX AORTIC VALVE IMPLANTED NINE (9) YEARS, EIGHT (8) MONTHS, WAS EXPLANTED 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 23085549 ↗
• InjurySep 16, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 10 MONTHS DUE TO SEVERE STENOSIS AND MILD REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE - SHORTNESS OF BREATH, LIGHTHEADEDNESS, AND DIZZINESS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY. PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN EXCELLENT CONDITION POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23069313 ↗
• InjurySep 15, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 4 MONTHS DUE TO DEGENERATION WITH REGURGITATION. PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH NON-EDWARDS DEVICE. PATIENT WAS STABLE AND DISCHARGED ON POD#1. THIS IS AN 80-YEAR-OLD MALE PATIENT.

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

  MAUDE report 23059926 ↗
• InjurySep 11, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 11 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS TAKEN TO ICU IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #8. 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

  MAUDE report 23031162 ↗
• InjurySep 9, 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 THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 4 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A INSPIRIS RESILIA 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: Chest Pain; Insufficient Information

  MAUDE report 23000807 ↗
• InjurySep 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 3300TFX AORTIC VALVE IN THE PULMONIC POSITION WAS EXPLANTED AND REPLACED WITH ANOTHER 27MM 3300TFX AORTIC VALVE AFTER AN IMPLANT DURATION OF 5 YEARS, 20 DAYS DUE TO UNKNOWN REASON. 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 22965757 ↗
• InjurySep 2, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 27MM 3300TFX AORTIC VALVE IMPLANTED NINE (9) YEARS, ONE (1) MONTH, WAS EVALUATED FOR VALVE-IN-VALVE PROCEDURE DUE TO MIXED AORTIC INSUFFICIENCY AND STENOSIS. PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. IT WAS REPORTED PATIENT SUCCESSFULLY UNDERWENT TAVR WITH A 26MM RESILIA TRANSCATHETER VALVE. PATIENT IS STABLE AND IS PLANNED FOR DISCHARGED ON POD# 1.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 22946385 ↗
• InjuryAug 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, AND TWO (2) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A AORTIC 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 22929078 ↗
• InjuryAug 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3300TFX VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS AND 6 MONTHS DUE TO AORTIC INSUFFICIENCY AND STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22912461 ↗
• InjuryAug 20, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 3300TFX VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE AND WAS DISCHARGED ON POD #1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22852256 ↗
• InjuryAug 18, 2025Calcified; Calcified

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 3300TFX 27MM AORTIC VALVE WAS EXPLANTED AND REPLACED AFTER AN IMPLANT DURATION OF 9 YEARS DUE TO CALCIFICATION. THE PATIENT PRESENTED WITH SOB. THE REPLACEMENT VALVE WAS UNKNOWN. 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 22830619 ↗