CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFX (REF 3300TFX21MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 533 adverse event reports that list this exact device (DI 00690103176131), received between Feb 4, 2021 and Aug 25, 2026 — classified as 5 deaths, 525 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (234 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 533 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Device Stenosis

  Patient problems: Chest Pain

  MAUDE report 50422126 ↗
• InjuryApr 27, 2026Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3300TFX PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, SEVEN (7) MONTHS DUE TO AORTIC STENOSIS. THE PATIENT INITIALLY PRESENTED WITH PROGRESSIVE SHORTNESS OF BREATH ON EXERTION WITH OCCASIONAL LIGHTHEADEDNESS OR DIZZINESS. DURING THE PROCEDURE, WITHIN MINUTES AFTER ADMINISTERING ANESTHESIA, THE PATIENT DECOMPENSATED AND WAS PUT ON ECMO. THE PATIENT WAS STABILIZED AND THE DECISION WAS MADE TO PROCEED WITH THE PROCEDURE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 25008445 ↗
• InjuryMar 31, 2026Calcified; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS AND 7 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PATIENT WAS PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN. THE VALVE WAS REPLACED WITH A 11500A 21MM AND THE PATIENT WAS TRANSFERRED TO THE ICU IN A STABLE CONDITION. THE PATIENT WAS DISCHARGED ON POD#4.

  Patient problems: Chest Pain; Dyspnea; Insufficient Information

  MAUDE report 24744435 ↗
• InjuryMar 31, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 3300TFX 21MM AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH ANOTHER 21MM 3300TFX VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24744408 ↗
• InjuryMar 30, 2026Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 7 MONTHS DUE TO LEAFLET CALCIFICATION, SEVERE STRUCTURAL DETERIORATION, AND DEHISCENCE. THE PATIENT PRESENTED WITH NYHA CLASS III HEART FAILURE AND SOB. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11600A VALVED CONDUIT. A 31MM 11400M MITRAL VALVE WAS IMPLANTED CONCOMITANTLY. THE PATIENT WAS TAKEN TO THE CVICU IN STABLE CONDITION POST PROCEDURE AND DISCHARGED POD #9. PER MEDICAL RECORDS, THE PATIENT IS A KNOWN CASE OF STAGE 3 CHRONIC KIDNEY DISEASE. SHE WAS RECENTLY ADMITTED FOR CHF EXACERBATION AND WAS FOUND TO HAVE NYHA CLASS III HEART FAILURE. DURING THAT ADMISSION, SHE HAD EXTENSIVE WORK-UP INCLUDING ECHO, CTA, AND CARDIAC CATH. SHE WAS STARTED ON ELIQUIS AS THERE WAS SOME CONCERN OF BIOPROSTHETIC VALVE THROMBOSIS WHICH WAS NOT CONFIRMED. THE PATIENT WAS EVENTUALLY DISCHARGED AND LATER PRESENTED TO THE CLINIC TO DO SOME TESTING INCLUDING ECHOCARDIOGRAM AND CAROTID ULTRASOUND. SHE HAS BEEN PROGRESSIVELY SOB AND UNABLE TO LIE FLAT DURING HER ECHO. HER TTE SHOWED ROCKING AORTIC VALVE DUE TO DEHISCENCE WITH SEVERE ST

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24731650 ↗
• InjuryMar 24, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 1 MONTH DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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: Insufficient Information

  MAUDE report 24682809 ↗
• InjuryMar 24, 2026Calcified

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 9 MONTHS DUE TO SEVERE CALCIFICATION, DEGENERATION, AND PANNUS FORMATION. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH AORTIC VALVE STENOSIS AND UNDERWENT A REDO AVR WITH ROOT ENLARGEMENT USING A BOVINE PERICARDIUM, ALONG WITH CABG X3 IN THE SAME PROCEDURE. INTRAOPERATIVELY, THE VALVE SHOWED SEVERE CALCIFIC DEGENERATION IN ALL THREE LEAFLETS. THE VALVE WAS EXPLANTED AND THE ANNULUS WAS CAREFULLY DEBRIDED. A 23MM 11500A VALVE WAS THEN IMPLANTED AND SECURED WITH COR-KNOTS. POST-OPERATIVE ECHO DEMONSTRATED A NORMALLY FUNCTIONING VALVE WITH NO PERIVALVULAR LEAK. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATIONS AND WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. ON POD #10, THE PATIENT WAS 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 REG

  Patient problems: Insufficient Information

  MAUDE report 24678240 ↗
• InjuryMar 23, 2026Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST PROCEDURE AND DISCHARGES ON POD #16.

  Patient problems: Dyspnea

  MAUDE report 24663775 ↗
• InjuryMar 20, 2026Calcified

  IT WAS REPORTED AND LATER LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 3300TFX MAGNA EASE AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 25MM 11500A RESILIA INSPIRIS VALVE AFTER AN IMPLANT DURATION OF 8 YEARS, 3 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH SOB AND FATIGUE. 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: Dyspnea

  MAUDE report 24652011 ↗
• InjuryMar 15, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, AND 23 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE 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; Syncope/Fainting

  MAUDE report 24602159 ↗
• InjuryMar 9, 2026Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO UNKNOWN REASON. 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 24542517 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, 10 MONTHS, DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11500A AORTIC 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 24533076 ↗
• InjuryFeb 18, 2026Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 10 MONTHS DUE TO CALCIFICATION AND STENOSIS. 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 #5. PER PATHOLOGY REPORT, THE EXPLANTED DEVICE'S 3 LEAFLETS WERE PRESENTED WITH NO CALCIFICATION, VEGETATIONS, OR HEMORRHAGE. 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 24382690 ↗
• InjuryJan 29, 2026Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 7 MONTHS DUE TO CALCIFICATION WITH SEVERE STENOSIS PATIENT PRESENTED WITH NYHA CLASS III HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH 23MM INSPIRIS RESILIA AORTIC VALVE. PER MEDICAL RECORDS, INTRAOPERATIVELY, AORTIC VALVE REVEALED SEVERELY CALCIFIED LEAFLETS. THE VALVE WAS REMOVED AND THE SURGEON PLACED A 23MM 11500A VALVE INTO PLACE. THE PATIENT WAS WEANED FROM CPB WITHOUT DIFFICULTY AND TEE DEMONSTRATED WELL-FUNCTIONING VALVE WITH NO REGURGITATION. THE PATIENT DISCHARGED ON POD#7. THIS IS A 65-YEAR-OLD FEMALE PATIENT. 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 P

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

  MAUDE report 24208556 ↗
• InjuryJan 29, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 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 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 24208446 ↗
• InjuryJan 16, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3300TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 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 24097230 ↗
• InjuryJan 16, 2026Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 5 MONTHS DUE TO UNKNOWN REASON. 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: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 24096396 ↗
• DeathJan 15, 2026Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 13 YEARS, 2 MONTHS DUE TO CALCIFICATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. PER VCC: PATIENT EXPIRED DUE TO NSTEMI, GI BLEED, ACUTE DECOMPENSATED HEART FAILURE WITH HYPOXEMIA AND SHOCK, EJECTION FRACTION OF 20%, NOT A CANDIDATE FOR TAVR DEEMED BY THE TEAM.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24090054 ↗
• InjuryJan 12, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 21MM 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: Dyspnea; Insufficient Information

  MAUDE report 24038390 ↗
• InjuryJan 6, 2026Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS DUE TO CALCIFICATION, DEGENERATION, AND CRITICAL STENOSIS. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11500A VALVE. HOSPITAL PATHOLOGY REPORT: GROSS EXAM OF AORTIC VALVE, CUSPS HAD MULTIPLE CALCIFICATIONS. FINAL DIAGNOSIS: BIOPROSTHETIC AORTIC VALVE WITH FIBROCALCIFIC DEGENERATION. THE DEVICE WAS DISCARDED. PER MEDICAL RECORDS, PRE-OPERATIVE ECHO SHOWED FINDINGS OF CRITICAL STENOSIS OF PROSTHETIC AORTIC VALVE WITH MG 86MMHG. THE PATIENT PRESENTED WITH HEART FAILURE NYHA III AND UNDERWENT REDO AVR. INTRAOPERATIVE INSPECTION OF THE AORTIC VALVE SHOWED DEGENERATION, DIFFICULT TO OPEN THE LEAFLETS, AND LARGE CALCIUM NODULE. THE VALVE WAS REMOVED AND A 23MM 11500A WAS IMPLANTED WITH NON-PLEDGETED MATTRESS SUTURES AND SECURED WITH COR-KNOTS. POST TEE SHOWED THE VALVE WELL SEATED WITH NO PVL. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION AND WAS DISCHARGED ON POD #13.

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

  MAUDE report 23976802 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS UNDERGOING VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 12 YEARS, 4 MONTHS DUE TO PPM WITH "ABNORMAL LEAFLET MOBILITY", WHEN PATIENT CRASHED REQUIRING CPR AND WAS CONVERTED TO OPEN HEART SURGERY. PATIENT PRESENTED WITH HEART FAILURE. PER INFORMATION RECEIVED, PATIENT WAS UNDERGOING BASILICA PROCEDURE WHEN PATIENT'S BLOOD PRESSURE DROPPED WITH LOW RV FUNCTION. ANESTHESIA ATTEMPTED STABILIZING THE PATIENT, BUT THE PATIENT WENT INTO ARREST, REQUIRING CPR. EFFUSION WAS NOTED ON ECHO AND PERICARDIOCENTESIS WAS ATTEMPTED BUT UNSUCCESSFUL. PATIENT WAS PLACED ON ECMO AND CT SURGEONS OPENED CHEST TO CONTROL BLEEDING. UNFORTUNATELY, THE SURGEONS WERE UNABLE TO REPAIR BLEEDING NOTED FROM AORTIC ANNULUS AND PATIENT EXPIRED THE SAME DAY. THE TRANSCATHETER VALVE NEVER ENTERED THE PATIENT AND WAS WASTED. THIS IS A 70-YEAR-OLD FEMALE PATIENT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23930767 ↗
• InjuryDec 16, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 6 MONTHS DUE TO LEAFLET CALCIFICATION, SEVERE STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SEVERE SOB, CHEST PAIN, AND NEAR SYNCOPE. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SEVERE SOB, CHEST PAIN, AND SYNCOPE. A PRE-OP ECHO (B)(6) 2025) INITIALLY SUGGESTED PPM AND ANOTHER PRE-OP ECHO (B)(6) 2025) REVEALED AORTIC STENOSIS. A REDO STERNOTOMY WAS PERFORMED TO EXPLANT AND REPLACE THE 21MM MANGA EASE WITH A 21MM INSPIRIS VALVE. INTRA-OPERATIVELY, A TEE CONFIRMED SEVERE AORTIC STENOSIS WITH REGURGITATION. THE PREVIOUSLY IMPLANTED VALVE WAS SEVERELY DEGENERATED WITH SIGNIFICANT THICKENING OF THE LEAFLETS AND CALCIFICATIONS BUILT-UP ALONG THE EDGE. THE OLD BIOPROSTHESIS WAS VERY CAREFULLY REMOVED AND A 21MM 11500A VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT WAS THEN WEANED FROM CARDIOPULMONARY BYPASS WITHOUT ANY DIFFICULTY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION AND THE PATIENT WAS TAKEN TO THE ICU IN STABLE CONDITION. THE PATIENT WAS

  Patient problems: Dyspnea

  MAUDE report 23821269 ↗
• InjuryDec 11, 2025Calcified; Patient Device Interaction Problem; Calcified; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 7 MONTHS DUE TO CALCIFICATION, PANNUS AND STENOSIS. THE PATIENT PRESENTED WITH SOB. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE. PER PATHOLOGY REPORT PROVIDED, THE VALVE CUSPS ARE FREELY MOBILE, WITH FOCAL AREAS OF CALCIFICATION AND WITH GROSS MODERATE PERIPHERAL LEAFLET PANNUS. 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 23782668 ↗
• InjuryDec 8, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO CALCIFICATION WITH STENOSIS. PATIENT PRESENTED WITH DYSPNEA, CHEST PAIN, AND FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A VALVED CONDUIT. THE PATIENT DISCHARGED ON POD#7. PER MEDICAL RECORDS, PATIENT PRESENTED WITH AORTIC ROOT DILATION. CARDIOLOGY STATES THAT PATIENT CURRENT AORTIC VALVE IS UNDERSIZED AND HAS FAILED, RESULTING IN SYMPTOMATIC AORTIC STENOSIS WITH DYSPNEA, FATIGUE, AND CHEST PAIN. PATIENT UNDERWENT ASCENDING AORTA + ROOT REPLACEMENT, AVR, LAA, AND TVR. INTRAOPERATIVELY, AORTIC VALVE WAS NOTED TO BE SEVERELY DETERIORATED WITH SIGNIFICANT PANNUS. A 25MM 11060A AORTIC VALVED CONDUIT WAS IMPLANTED IN REPLACEMENT. PATIENT TOLERATED THE PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS AND DISCHARGED ON POD#7. PER PATHOLOGY, EXPLANTED AORTIC VALVE CONSISTED OF SEVERE CALCIFICATION WITH MILD PANNUS. 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), RA

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23739255 ↗
• InjuryDec 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 6 MONTHS DUE TO UNKNOWN REASON. 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 23696527 ↗