CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFX (REF 3300TFX23MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 671 adverse event reports that list this exact device (DI 00690103176148), received between Feb 22, 2021 and Sep 14, 2026 — classified as 4 deaths, 665 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (323 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 671 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Insufficient Device Problem Information

  It was learned through Implant Patient Registry that a patient with a 23mm 3300TFX aortic valve was explanted after an implant duration of 7 years due to unknown reasons. The explanted valve was replaced with a 23mm 11060A 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 50753537 ↗
• InjuryAug 3, 2026Calcified; Insufficient Device Problem Information

  It was learned through Implant Patient Registry that a patient with a 23mm 3300TFX aortic valve was explanted after an implant duration of 9 years, 8 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: Dyspnea; Insufficient Information

  MAUDE report 50114147 ↗
• MalfunctionJul 28, 2026Defective Device

  \[redacted]"--- When replacing the aortic valve, the first tissue valve was not functioning properly. It was discovered on TEE \[transesophageal echocardiogram]" when trying to come off bypass. Decided by MD to replace the valve. Procedure required more time on bypass. Second valve worked properly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053696 ↗
• InjuryJun 9, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 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 25447965 ↗
• InjuryMay 20, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 9 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11500A AORTIC 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: Insufficient Information

  MAUDE report 25231873 ↗
• InjuryMay 18, 2026Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 6 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH SOB AND CHEST PAIN. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE 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 25209010 ↗
• InjuryApr 29, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 5 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 25033436 ↗
• InjuryApr 26, 2026Degraded

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF (B)(6) DUE TO DEGENERATION AND STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS STABLE AND IN RECOVERY POST-PROCEDURE. ON POD #7 PPM WAS PLACED DUE TO HEART BLOCK AND THE PATIENT DISCHARGED ON POD #8.

  Patient problems: Dyspnea; Heart Block

  MAUDE report 24993634 ↗
• InjuryApr 10, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO HIGH GRADIENTS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE PATIENT WAS IN RECOVERY. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND WAS DISCHARGED ON POD#5.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 24841629 ↗
• InjuryApr 8, 2026Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO CALCIFICATION WITH STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH NO CARDIAC SYMPTOMS BUT HAD INCREASING GRADIENTS. HE UNDERWENT REDO AVR, THE 3300TFX WAS EXPLANTED AND ONE OF THE LEAFLETS WAS CALCIFIED, PRESUMED THIS CONTRIBUTED TO THE STENOSIS. AFTER DEBRIDEMENT OF THE ANNULUS, A 29MM 11500A VALVE WAS IMPLANTED WITH PLEDGETED SUTURES, SEATED, AND SECURED WITH COR-KNOTS. THE PATIENT REMAINED STABLE, RETURNED TO THE SURGICAL ICU, AND WAS DISCHARGED ON POD #6. HOSPITAL PATHOLOGY REPORT: GROSS EXAM, PROSTHETIC AORTIC VALVE WITH ATTACHED LEAFLETS, ONE LEAFLET HAS AN AREA OF WHITE EXUDATE. ALSO RECEIVED ARE MULTIPLE WHITE FRAGMENT OF SOFT TISSUE WITH CALCIFICATIONS. FINAL DIAGNOSIS: AORTIC VALVE, NEGATIVE FOR ACTIVE INFLAMMATION. 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 THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824602 ↗
• InjuryApr 8, 2026Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 6 MONTHS DUE TO DEGENERATION, SEVERE STENOSIS AND REGURGITATION. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A AORTIC VALVED CONDUIT. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH HEART FAILURE NYHA-3 AND UNDERWENT REDO AVR WITH BENTALL PROCEDURE. THE AORTIC VALVE WAS REMOVED AND REPLACED WITH A 23MM AVC WITH MATTRESS SUTURES AND SECURED WITH COR-KNOTS. POST BYPASS TEE SHOWED WELL-SEATED AORTIC VALVE WITH NO PVL. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION AND WAS DISCHARGED ON POD #17. HOSPITAL PATHOLOGY REPORT: GROSS EXAM ONLY, AORTIC VALVE WITH MILD DEGENERATIVE CHANGES. 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 DAT

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24824585 ↗
• InjuryMar 31, 2026Perivalvular Leak; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 3300TFX 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: Hemodynamic instability; Insufficient Information

  MAUDE report 24750076 ↗
• InjuryMar 31, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 3300TFX MAGNA EASE VALVE IN THE AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 23MM 11500A INSPIRIS RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 7 YEARS, 28 DAYS. REASON FOR REINTERVENTION IS 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: Chest Pain; Dizziness; Fatigue; Insufficient Information

  MAUDE report 24749604 ↗
• InjuryMar 30, 2026Device Stenosis

  IT WAS REPORTED AND 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 STENOSIS. PATIENT PRESENTED WITH FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A INSPIRIS RESILIA AORTIC VALVE.

  Patient problems: Fatigue

  MAUDE report 24728121 ↗
• InjuryMar 20, 2026Calcified; Degraded; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 3300TFX MAGNA EASE VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 23MM 11500A INSPIRIS RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO DEGENERATION AND CALCIFICATION. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. PATIENT WAS RECOVERED POST-OPERATIVELY.

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

  MAUDE report 24656170 ↗
• InjuryMar 20, 2026Insufficient Device Problem Information; Material Split, Cut or Torn

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 3300TFX MAGNA EASE AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO LEAFLET PROLAPSE RESULTING IN REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE REPLACEMENT VALVE IS A 23MM 11500A INSPIRIS RESILIA AORTIC VALVE.

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

  MAUDE report 24656130 ↗
• InjuryMar 20, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS AND 5 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 11500A 25MM VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24654543 ↗
• InjuryMar 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23MM 3300TFX VALVE IN AORTIC POSITION UNDERWENT AN ATTEMPTED VIV PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, NINE (9) MONTHS DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, AFTER A FEW ATTEMPTS WERE MADE WITH THE COMMANDER SYSTEM OF THE SAPIEN VALVE, WITH DIFFICULTY KEEPING THE WIRE IN THE VENTRICLE, AND CONVERSATIONS ABOUT WHAT WOULD BE BEST AND SAFEST FOR THE PATIENT, THEY DECIDED TO ABORT THE CASE AND DISCUSS OPTIONS WITH THE PATIENT. THE AORTIC REPLACEMENT, ANGULATION, AND DIFFICULTY CROSSING A WIRE THROUGH THE HEAVILY CALCIFIED ANNULUS WERE ALL REASONS TO ABORT AND CONSIDER ALTERNATIVE OPTIONS. THE IMPLANTING PHYSICIAN ALSO STATED THAT THE SURGICAL VALVE WAS TOO SMALL FOR THE ANATOMY, CAUSING AN EARLY FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 24653635 ↗
• InjuryMar 14, 2026Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 3 MONTHS DUE TO CALCIFICATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND VERTIGO WITH STANDING. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND WAS DISCHARGE ON POD#7. 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; Vertigo

  MAUDE report 24599683 ↗
• InjuryFeb 27, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3300TFX PERICARDIAL VALVE IN THE PULMONARY POSITION UNDERWENT REDO PULMONARY VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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 24472494 ↗
• InjuryFeb 19, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 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 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 24393072 ↗
• InjuryFeb 19, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTH DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE 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: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 24388372 ↗
• InjuryFeb 13, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 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 27MM 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 24338697 ↗
• InjuryFeb 12, 2026Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 9 MONTHS DUE TO DEGENERATION. THE PATIENT PRESENTED WITH SOB. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED POD #11. 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 24328978 ↗
• InjuryFeb 6, 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 23MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF (B)(6) DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. PATIENT DISCHARGE ON POD#8. PER PATHOLOGY REPORT, AORTIC VALVE AND GRAFT WITH ENDOCARDITIS. LEAFLETS WITH FRIABLE VEGETATIONS.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24284757 ↗