CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFX (REF 7300TFX33)Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 00690103186291), received between Mar 18, 2021 and May 18, 2026 — classified as 2 deaths, 138 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (67 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 142 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Calcified; Perivalvular Leak; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 2 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 11400M 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 25211286 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 33MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 5 MONTHS DUE TO ENTEROCOCCUS FAECALIS ENDOCARDITIS. THE EXPLANTED DEVICE WAS REPLACED WITH A 33MM 11400M MITRAL VALVE. PER MEDICAL RECORDS, PATIENT PRESENTED WITH SHORTNESS OF BREATH, TEE/ECHO SHOWED LARGE MOBILE MASS ON MITRAL ANTERIOR LEAFLET. BLOOD CULTURES + ENTEROCOCCUS FAECALIS; SUSPECTED DENTAL SOURCE. THE PATIENT UNDERWENT A REDO MVR AND INSERTION OF LVAD/IMPELLA DEVICE. THE MITRAL PROSTHETIC VALVE HAD SEVERAL VEGETATIONS, AFTER DEBRIDEMENT, THE ANTERIOR LEAFLET WAS RESECTED, PRESERVING ATTACHMENT TO PAPILLARY MUSCLE. A 33MM 11400M VALVE WAS THEN IMPLANTED WITH PLEDGETED SUTURES. POST BYPASS TEE SHOWED GOOD FUNCTION OF THE LV AND NO MITRAL PVL. THE PATIENT WAS TRANSFERRED TO ICU IN GUARDED CONDITION. ON POD #8, THE IMPELLA DEVICE WAS REMOVED. ON POD #13, RE-IMPLANTED CRT-D DUE TO ENDOCARDITIS.

  Patient problems: Insufficient Information

  MAUDE report 24715280 ↗
• InjuryMar 25, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 7 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M 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 24692515 ↗
• InjuryFeb 26, 2026Degraded; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 33MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, AND 11 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M MITRAL 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 24463611 ↗
• InjuryFeb 12, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 33MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 29MM 11400M MITRIS 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 24324724 ↗
• InjuryDec 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M 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: Insufficient Information

  MAUDE report 23885552 ↗
• InjuryDec 19, 2025Calcified; Patient Device Interaction Problem; Device Stenosis; Calcified; Patient Device Interaction Problem; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 1 MONTH DUE TO CALCIFICATION, WITH PANNUS AND STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, VERTIGO AND ENDURANCE. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 11400M VALVE. PATIENT WAS IN RECOVERY POST PROCEDURE. THE PATIENT WAS DISCHARGED ON POD#9. PER PATHOLOGY REPORT: FINAL DIAGNOSIS WITH CALCIFICATION AND FIBROSIS. GROSS DESCRIPTION; CARPENTIER-EDWARDS MITRAL VALVE BIOPROSTHESIS WITH CALCIFICATIONS, WITH NO CUSP TEARS, WITHOUT THROMBUS, WITH OBSTRUCTIVE FIBROUS INGROWTH (PANNUS), AND WITHOUT VEGETATIONS.

  Patient problems: Dyspnea; Vertigo

  MAUDE report 23854905 ↗
• InjuryDec 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33 MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 4 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31 MM 11400 M MITRIS RESILIA MITRAL 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 23679405 ↗
• InjuryNov 21, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 33MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. THE EXPLANTED DEVICE WAS REPLACED WITH A 33MM 11400M VALVE. CONCOMITANTLY A 33MM 11400M MITRAL VALVE WAS IMPLANTED IN THE TRICUSPID POSITION. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON POD #9. 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 23619154 ↗
• InjuryNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE IMPLANT PATIENT REGISTRY THAT A 33MM 7300TFX MITRAL VALVE IN MITRAL POSITION WAS EXPLANTED AND REPLACED WITH A 29MM 11400M MITRIS MITRAL VALVE AFTER AN IMPLANT DURATION OF 8 YEARS, AND 7 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 23568934 ↗
• DeathNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE EXPIRED SEVERAL DAYS POST PROCEDURE DUE TO INTRACRANIAL HEMORRHAGE AND ENDOCARDITIS.

  Patient problems: Endocarditis

  MAUDE report 23551616 ↗
• InjurySep 18, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 6 MONTHS DUE TO REGURGITATION. THE TTVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Insufficient Information; Swelling/ Edema; Syncope/Fainting

  MAUDE report 23086263 ↗
• InjurySep 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, EIGHT (8) MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH FATIGUE, CHEST PRESSURE, AND DRY COUGH. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS TAKEN TO RECOVERY AFTERWARDS.

  Patient problems: Chest Pain; Cough; Fatigue

  MAUDE report 23057287 ↗
• InjurySep 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 1 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 33MM 7300TFX MITRAL 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 22956470 ↗
• InjurySep 2, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE HAS BEEN PLACED UNDER EVALUATION FOR A DOUBLE VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS, 8 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE. PER MEDICAL RECORDS, ECHO DEMONSTRATED MITRAL STENOSIS, MILD TO MODERATE TRICUSPID REGURGITATION, AND AORTIC STENOSIS. THE PATIENT WENT INTO CARDIOGENIC SHOCK DUE TO CRITICAL MITRAL STENOSIS WITH MULTIORGAN FAILURE, HYPOXIC RESPIRATORY FAILURE AND HAS CONTAMINANT BIOPROSTHETIC MODERATE TO SEVERE AORTIC STENOSIS AND MODERATE REGURGITATION. PER PHYSICIAN, THE PATIENT IS TOO ILL FOR SURGICAL OR TRANSCATHETER VALVE REPLACEMENT FOR AORTIC AND MITRAL VALVE AT THIS TIME.

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

  MAUDE report 22938894 ↗
• InjurySep 2, 2025Thickening of Material; Device Stenosis; Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 9 MONTHS DUE TO FIXED AND THICKENED LEAFLET WITH STENOSIS AND REGURGITATION. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE PROCEDURE WAS PERFORMED WITH 29MM 9755RSL. TRANSCATHETER VALVE. THIS IS A 48-YEAR MALE PATIENT.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22936897 ↗
• InjuryAug 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 4 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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 22912534 ↗
• InjuryAug 27, 2025Degraded; Device Stenosis; Degraded; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS DUE TO MITRAL STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PROCEDURE IS SCHEDULED.

  Patient problems: Dyspnea

  MAUDE report 22908552 ↗
• InjuryAug 25, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22882619 ↗
• InjuryAug 25, 2025Calcified; Intravalvular regurgitation; Calcified; Intravalvular regurgitation

  IT WAS LEARNED THROUGH PATIENT SUPPORT CENTER THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 9 MONTHS DUE TO CALCIFICATION AND SEVERE LEAK. PATIENT PRESENTED WITH HEART FAILURE , SHORTNESS OF BREATH AND FLUID RETENTION. THE PROCEDURE WAS PERFORMED WITH 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22882589 ↗
• InjuryAug 11, 2025Calcified; Device Stenosis; Intravalvular regurgitation; Calcified; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS AND 10 MONTHS DUE TO CALCIFICATION, SEVERE STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH DYSPNEA AND HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSLTFX TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE. PER MEDICAL RECORDS, INTRAOPERATIVELY, PROSTHETIC VALVE LEAFLETS ARE THICKENED WITH FUSION NOTED BETWEEN THE POSTERIOR MEDIAL AND POSTERIOR LATERAL ORIENTED VALVE LEAFLET. THIS RESULTS IN REDUCED LEAFLET EXCURSIONS. CONSISTENT WITH BIOPROSTHETIC VALVE DEGENERATION WITH BIOPROSTHETIC VALVE STENOSIS. THE PROSTHETIC AORTIC VALVE 25 MM MAGNA PERICARDIAL NOTED TO BE WELL-SEATED, LEAFLETS APPEAR NORMAL IN THICKNESS WITH NORMAL LEAFLET MOBILITY.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 22778078 ↗
• InjuryAug 8, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE WAS UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 10 YEARS AND 1 MONTH DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. IT WAS LEARNED PATIENT SUCCESSFULLY UNDERWENT TMVR WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS RECOVERING IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22751095 ↗
• InjuryAug 8, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, SIX (6) MONTHS DUE TO CALCIFICATION. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE. THE TMVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THERE WAS NO CENTRAL LEAK.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22746651 ↗
• InjuryAug 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX PERICARDIAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE. THE TTVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE WITH NO CENTRAL LEAK.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22746602 ↗
• InjuryAug 4, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 33MM 7300TFX MITRAL VALVE, IMPLANTED FOR 9 YEARS AND 1 MONTH UNDERWENT ATTEMPTED VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. TEE SHOWED A LARGE CLOT IN THE LEFT ATRIUM AND PROCEDURE WAS CANCELLED. PLAN IS FOR REPEAT TEE ON (B)(6) 2025 AND IF CLOT HAS RESOLVED PATIENT WILL BE SCHEDULED FOR TMVR ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22709238 ↗