CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFX (REF 3300TFX25MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 656 adverse event reports that list this exact device (DI 00690103176155), received between Feb 9, 2021 and Sep 24, 2026 — classified as 1 death, 655 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (304 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 656 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Insufficient Device Problem Information

  It was learned through Implant Patient Registry that a 25mm 3300TFX Magna Ease aortic valve in aortic position was explanted after an implant duration of 5 years, 9 months. The replacement valve is another 25mm 3300TFX aortic valve. 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 50884990 ↗
• InjurySep 12, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50744717 ↗
• InjurySep 11, 2026Calcified

  Patient problems: Cardiogenic Shock

  MAUDE report 50739507 ↗
• InjurySep 9, 2026Insufficient Device Problem Information

  It was learned through Implant Patient Registry that a patient with a 25mm 3300TFX aortic valve was explanted after an implant duration of 7 years, 9 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 50690822 ↗
• InjuryAug 31, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50519491 ↗
• InjuryAug 23, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50396598 ↗
• InjuryAug 23, 2026Degraded; Insufficient Device Problem Information

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 50396384 ↗
• InjuryJun 5, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. 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: Insufficient Information

  MAUDE report 25414905 ↗
• InjuryMay 22, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS. 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: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 25262974 ↗
• InjuryMay 5, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY A 25MM 3300TFX AORTIC VALVE IMPLANTED SEVEN (7) YEARS, 11 MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 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 25088099 ↗
• InjuryApr 27, 2026Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25 MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 10 YEARS, 11 MONTHS DUE TO DEGENERATION AND CENTRAL REGURGITATION. THE PATIENT PRESENTED WITH NEW LV DYSFUNCTION/DILATION. THE TAVR WAS PERFORMED WITH A 26 MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED. 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: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 25008025 ↗
• InjuryApr 13, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3300TFX MAGNA EASE AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 25MM 11500A INSPIRIS RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 3 YEARS, 10 MONTHS. REASON FOR REINTERVENTION WAS NOT PROVIDED. 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: Insufficient Information

  MAUDE report 24854068 ↗
• InjuryApr 7, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF (B)(6) DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 25MM 11500A AORTIC VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24810445 ↗
• InjuryMar 31, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 2 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 24749380 ↗
• InjuryMar 17, 2026Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 10 MONTHS DUE TO CALCIFICATION AND AORTIC INSUFFICIENCY. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11500A AORTIC VALVE. HOSPITAL PATHOLOGY REPORT: GROSS EXAM OF PROSTHETIC AORTIC VALVE, INCLUDED FINDINGS OF AGGREGATE OF RAGGED, IRREGULARLY SHAPED, TAN-YELLOW, PARTIALLY CALCIFIED FRAGMENTS OF TISSUE. FINAL DIAGNOSIS, VALVE LEAFLETS WITH CALCIFICATION AND ACUTE INFLAMMATION.

  Patient problems: Insufficient Information

  MAUDE report 24617671 ↗
• InjuryMar 17, 2026Degraded; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND RECORDS THAT A PATIENT WITH A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 8 MONTHS DUE TO DEGENERATION WITH THICKENED LEAFLETS AND SEVERE STENOSIS. PATIENT PRESENTED IN HEART FAILURE WITH CHEST PAIN. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A INSPIRIS RESILIA AORTIC VALVE. INTRAOPERATIVELY, PREVIOUS AORTIC VALVE SHOWED CLEAR EVIDENCE OF DEGENERATION. VALVE WAS EXPLANTED AND REPLACED WITH A 23MM 11500A AORTIC VALVE. THE PATIENT ALSO UNDERWENT MVR OF NATIVE VALVE. TEE DEMONSTRATED GOOD SEATING WITH NO PVL. PATIENT WAS SENT TO OPACU IN STABLE BUT CRITICAL CONDITION AND DISCHARGED ON POD#19.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24617211 ↗
• InjuryMar 16, 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 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 2 MONTHS DUE TO ENDOCARDITIS, WITH THICKENED LEAFLETS AND STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. PER MEDICAL RECORDS, ECHO SHOWED LEAFLETS THICKENED, HIGH GRADIENT AND MILD AI. THE PATIENT PRESENTED WITH NYHA CLASS II SYMPTOMS. THE PATIENT UNDERWENT REDO-AVR WITH A 23MM INSPIRIS VALVE. THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24612962 ↗
• InjuryMar 16, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 10 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 3300TFX VALVE. THE PATIENT WAS REPORTED TO BE IN RECOVERY POST-PROCEDURE. PER THE IMPLANTATION DATA CARD, THERE WAS NO DEFICIENCY IN THE ORIGINAL DEVICE. 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 24612848 ↗
• InjuryMar 9, 2026Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 11 YEARS, 3 MONTHS DUE TO MODERATE CALCIFICATION AND CRITICAL STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE TAVR AND SURGICAL LEAFLET MODIFICATION WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS DISCHARGED HOME ON POD #1. PER MEDICAL RECORDS, THE PATIENT PRESENTED TO THE HOSPITAL WITH ACUTE SYSTOLIC CHF. HEART CATH SHOWED, MODERATELY THICKEN AND CALCIFIED AORTIC VALVE LEAFLETS WITH CRITICAL AORTIC STENOSIS. PATIENT WAS WORKED UP FOR PCI/TAVR AND WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TAVR PROCEDURE; CARDIOLOGIST DECIDED TO PERFORM A PCI/STENT ((B)(6) 2026) AND DISCHARGED PATIENT HOME. TAVR/VIV WAS PERFORMED 8 DAYS LATER.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24547046 ↗
• InjuryMar 4, 2026Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 1 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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 24514064 ↗
• InjuryMar 2, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS AND 10 MONTHS DUE TO STENOSIS. THE PATIENT WAS PRESENTED WITH SHORTNESS OF BREATH. THE VALVE WAS REPLACED WITH A 25MM 11060A BIOPROSTHETIC VALVE. THE PATIENT WAS SENT TO RECOVERY POST PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 24491847 ↗
• InjuryFeb 27, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3300TFX IMPLANTED IN THE AORTIC POSITION WAS EXPLANTED AND REPLACED WITH AN UNKNOWN VALVE AFTER AN IMPLANT DURATION OF 9 YEARS, 8 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 24472125 ↗
• InjuryFeb 20, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 11 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 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 24401572 ↗
• InjuryFeb 13, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3300TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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 24339492 ↗
• InjuryFeb 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3300TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 3300TFX PERICARDIAL 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 24281254 ↗