CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFX (REF 3300TFX19MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00690103176124), received between Jun 7, 2021 and Sep 14, 2026 — classified as 92 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (43 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 95 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50765034 ↗
• InjurySep 11, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50744490 ↗
• InjuryFeb 5, 2026Degraded; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 19MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO DEGENERATION, PANNUS AND PPM. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, CHEST PAIN AND SYNCOPE. THE EXPLANTED DEVICE WAS REPLACED WITH A 21MM 11500A AORTIC VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE AND DISCHARGED ON POD #64. 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; Syncope/Fainting

  MAUDE report 24273862 ↗
• InjuryFeb 4, 2026Degraded

  PER THE REPORT RECEIVED FROM THE UNITED KINGDOM, EDWARDS RECEIVED NOTIFICATION THAT THIS PATIENT WITH A 3300TFX19MM VALVE IMPLANTED IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOURTEEN (14) YEARS AND NINE (9) MONTHS DUE TO DEGENERATION. THE PATIENT PRESENTED WITH DYSPNEA AND OCCASIONAL DIZZINESS AND JAW PAIN BEFORE THE REINTERVENTION. A TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED WITHIN THE EDWARDS SURGICAL VALVE. THE PATIENT HAD A RIGHT BUNDLE BRANCH BLOCK (BBBB) WITH LEFT HEMIBLOCK PRE-PROCEDURE, AND A COMPLETE HEART BLOCK (CHB) POST-PROCEDURE, NEEDING A PACEMAKER. THE PATIENT WAS NOTED AS TO BE IN STABLE CONDITION.

  Patient problems: Dyspnea

  MAUDE report 24257941 ↗
• InjurySep 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE , IMPLANTED IN THE PULMONIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A INSPIRIS RESILIA 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 23042694 ↗
• InjurySep 5, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 19MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, AND EIGHT (8) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A 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: Dyspnea; Fatigue; Insufficient Information

  MAUDE report 22986780 ↗
• InjuryAug 25, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO STENOSIS (MG 75). THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 20MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #11. PER FCS/EW1: VALVE INTENTIONALLY DEPLOYED ABOVE THE SURGICAL VALVE SEWING RING TO SUPPORT VECTOR PROCEDURE, PATIENT WAS ON ECMO.

  Patient problems: Dyspnea

  MAUDE report 22885429 ↗
• InjuryAug 22, 2025Calcified; Calcified

  IT WAS REPORTED AND PER ADDITIONAL INFORMATION THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 20MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 22879562 ↗
• InjuryJul 21, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, FOUR (4) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY. PATIENT WAS IN STABLE CONDITION POST PROCEDURE. PATIENT WAS DISCHARGED ON POD #5.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22556539 ↗
• InjuryJul 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS AND 11 MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 20MM 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 22489943 ↗
• InjuryJul 8, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 4 MONTHS DUE TO CALCIFICATION WITH STENOSIS. HOSPITAL PATHOLOGY REPORT: MICROSCOPIC EXAM, EXPLANTED BIOPROSTHETIC AORTIC VALVE WITH DYSTROPHIC CALCIFICATION. CLINICAL INFORMATION: AORTIC STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 22442173 ↗
• InjuryJul 2, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 6 MONTHS DUE TO STENOSIS.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22384002 ↗
• InjuryJun 17, 2025Intravalvular regurgitation; Intravalvular regurgitation

  EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH A 19MM 3300TFXJ AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS AND ETEN (10) MONTHS DUE TO AORTIC REGURGITATION. THE DEVICE WAS REPLACED WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE SUCCESSFULLY. THE PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22235714 ↗
• InjuryJun 2, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 19MM 3300TFX AORTIC VALVE IMPLANTED SEVEN (7) YEARS, FIVE (5) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO AORTIC STENOSIS. TAVR WAS SUCCESSFULLY PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE.

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

  MAUDE report 22127262 ↗
• InjuryMay 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, ONE (1) MONTH DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 23MM 9600TFX TRANSCATHETER VALVE SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22071653 ↗
• InjuryMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 1 MONTH DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A 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 21987347 ↗
• InjuryMay 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19MM 3300TFX VALVE, IMPLANTED IN AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS AND 10 MONTHS DUE TO UNKNOWN REASONS. THE VALVE WAS REPLACED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21945546 ↗
• InjuryApr 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 19MM 3300TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, AND 11 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 21880546 ↗
• InjuryApr 4, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE IN AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 10 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SEVERE SHORTNESS OF BREATH.. THE TAVR WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND WAS DISCHARGED ON POD # 1. 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 21775434 ↗
• InjuryApr 2, 2025Calcified; Calcified

  IT WAS REPORTED THAT A 3300TFX 19MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 21MM AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTH DUE TO CALCIFICATION, DEGENERATION, LEAFLET RESTRICTION, AND SEVERE STENOSIS. THE PATIENT WAS IN ICU.

  Patient problems: Insufficient Information

  MAUDE report 21755667 ↗
• InjuryMar 25, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO CALCIFICATION. THE PATIENT HAS ALSO BEEN EVALUATED FOR HER 25MM 7300TFX MITRAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21689923 ↗
• InjuryMar 20, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 7 MONTHS DUE TO LEAFLET CALCIFICATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH.

  Patient problems: Dyspnea

  MAUDE report 21653227 ↗
• InjuryMar 13, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 6 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SOB. THE PROCEDURE WAS PERFORMED WITH A 20MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGED POD #13.

  Patient problems: Dyspnea

  MAUDE report 21600841 ↗
• InjuryFeb 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 21425404 ↗
• InjuryFeb 3, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 19 MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS AND SEVEN (7) MONTHS DUE TO STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 21290974 ↗