CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFX (REF 7300TFX29)Recalls & reported problems

Summary

The FDA's MAUDE database contains 391 adverse event reports that list this exact device (DI 00690103186277), received between Jan 28, 2021 and Aug 28, 2026 — classified as 1 death, 387 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (156 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 391 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50501210 ↗
• InjuryAug 17, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50290054 ↗
• InjuryJun 19, 2026Degraded

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE IS UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 13 YEARS, 7 MONTHS DUE TO STRUCTURAL VALVE DETERIORATION AND SEVERE MITRAL STENOSIS. THE PATIENT PRESENTED WITH NYHA CLASS III IV HEART FAILURE , SHORTNESS OF BREATH WITH MINIMAL ACTIVITY, PROGRESSIVE FATIGUE, LOWER EXTREMITY EDEMA. PER MEDICAL RECORDS, PRE OP TTE DEMONSTRATED MEAN GRADIENT UP TO 13.5 MMHG, TRIVIAL MITRAL REGURGITATION, SEVERE TRICUSPID REGURGITATION, RIGHT VENTRICULAR SYSTOLIC PRESSURE 80 MMHG, EJECTION FRACTION 70%, AND ASCENDING AORTA 46 MM. THE PATIENT UNDERWENT INDUCTION FOR TRANSCATHETER MITRAL VALVE REPLACEMENT, HOWEVER DEVELOPED CARDIOGENIC SHOCK WITH DECOMPENSATED RIGHT HEART FAILURE, FOLLOWED BY PEA ARREST REQUIRING CPR AND EPINEPHRINE AND VENTRICULAR TACHYCARDIA TREATED WITH AMIODARONE. TEE DEMONSTRATED SEVERE RV DYSFUNCTION AND BILATERAL PLEURAL EFFUSIONS. THE PROCEDURE WAS ABORTED DUE TO DECOMPENSATION ON INDUCTION OF ANESTHESIA. POST PROCEDURALLY, THE PATIENT DEVELOPED ACUTE HYPOXEMIC RESPIRATORY FAILURE, BILATERAL PLEURAL EFFUSIONS REQUIRING THORACOSTOMY WITH GREATER 3 L OU

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25568237 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT REDO MITRAL VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, EIGHT (8) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M MITRIS 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 24735979 ↗
• InjuryMar 25, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 7300TFX VALVE, IMPLANTED IN TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS AND 9 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 27MM 11400M VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24684286 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 7300TFX VALVE, IMPLANTED IN TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 29MM 11400M VALVE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24539212 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, AND ONE (1) MONTH DUE TO DEGENERATION AND STENOSIS. THE PATIENT PRESENTED DYSPNEA. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400 MITRAL VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 24538923 ↗
• InjuryMar 4, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 6 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 24508811 ↗
• InjuryFeb 26, 2026Patient Device Interaction Problem

  EDWARDS REVIEWED THE LITERATURE ARTICLE, SIMULTANEOUS TRANSCATHETER TRICUSPID VIV AND MITRAL VIV REPLACEMENT WITH LAMPOON IN A PATIENT WITH EARLY BIOPROSTHETIC MV AND TV DYSFUNCTION FROM HALT, APRIL 1, 2025. IT WAS LEARNED THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 2 MONTHS DUE TO THROMBOSIS/HALT AND TORRENTIAL TRICUSPID REGURGITATION. THE TTVR WAS PERFORMED WITH A 29MM 9755RSL. PER CLINICAL CASE, THE PATIENT PRESENTED WITH PROGRESSIVE FATIGUE, SHORTNESS OF BREATH, SIGNIFICANT VOLUME OVERLOAD. PRE-OPERATIVE TEE SHOWED AN IMMOBILE, THICKENED LATERAL BIOPROSTHETIC MV LEAFLET LEADING TO SEVERE MR. SHORT, THICKENED, IMMOBILE BIOPROSTHETIC TV LEAFLETS LEADING TO TORRENTIAL TR. CARDIAC CT REVEALED MV AND TV LEAFLET THROMBOSIS WITH EVIDENCE OF HALT AND REDUCED LEAFLET MOBILITY. ANTICOAGULATION THERAPY WAS INITIATED HOWEVER PATIENT CONTINUED TO HAVE PERSISTENT SYMPTOMS AND VALVULAR DYSFUNCTION AND UNDERWENT VALVE-IN-VALVE. POST-PROCEDURE TTE SHOWED WELL SEATED MV AND TV WITH NO RESIDUAL MR OR TR.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24462522 ↗
• InjuryFeb 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 9 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 24281252 ↗
• InjuryFeb 3, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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. 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 SU

  Patient problems: Insufficient Information

  MAUDE report 24252852 ↗
• InjuryJan 29, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 7300TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. 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 24208494 ↗
• InjuryJan 23, 2026Perivalvular Leak

  IT WAS LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE UNDERWENT A PERCUTANEOUS INTERVENTION TO REPAIR MITRAL PVL AFTER AN UNKNOWN IMPLANT DURATION. THE PROCEDURE WAS PERFORMED WITH 2 VSD OCCLUDERS (6 AND 4 MM).

  Patient problems: Insufficient Information

  MAUDE report 24167329 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, AND NINE (9) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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 24032906 ↗
• InjuryJan 12, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, AND FIVE (5) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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: Insufficient Information

  MAUDE report 24032889 ↗
• InjuryJan 7, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE IMPLANTED IN THE TRICUSPID POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 8 MONTHS DUE TO UNKNOWN REASON. 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 23989746 ↗
• InjuryJan 1, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) YEARS, AND FOUR (4) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M MITRAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23940821 ↗
• InjuryDec 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 7300TFX PERICARDIAL MITRAL VALVE [2025-32899-01] AND 31MM 7300TFX PERICARDIAL VALVE IN THE TRICUSPID POSITION [2025-32899-02] UNDERWENT SIMULTANEOUS REDO MITRAL AND TRICUSPID VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVES WERE REPLACED WITH A 31MM 11400M MITRIS VALVE IN THE MITRAL POSITION AND ANOTHER 31MM 11400M MITRIS VALVE IN THE TRICUSPID POSITION. 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 23811510 ↗
• InjuryDec 9, 2025Degraded; Degraded

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORD THAT A 29MM 7300TFX MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 10 MONTHS DUE TO DEGENERATION WITH MIXED VALVE DISEASE AND FUSED LEAFLET. THE PATIENT PRESENTED WITH HEART FAILURE, FOLLOWING EXTENSIVE HOSPITALIZATION FOR HEART FAILURE SYMPTOM MANAGEMENT. TMVR WAS COMPLETED WITH A 29MM 9755RSL TRANSCATHETER VALVE. PER MEDICAL RECORDS, TEE DEMONSTRATED MODERATE ECCENTRIC MITRAL REGURGITATION WITH SEVERELY RESTRICTED MOBILITY OF LEAFLETS AND STENOSIS. CARDIOLOGY NOTED DEGENERATIVE MS FINDINGS AND RECOMMENDED TMVR. PATIENT UNDERWENT SUCCESSFUL TMVR WITH IMPROVEMENT IN SYMPTOMS.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23764121 ↗
• InjuryDec 3, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 22 DAYS DUE TO SEVERE MITRAL STENOSIS AND MITRAL INSUFFICIENCY. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH DYSPNEA, ANGINA, AND ORTHOPNEA. ECHO REVEALED SEVERE MITRAL STENOSIS WITH MEAN GRADIENT OF 13 MMHG. THE VALVE WAS EXPLANTED AND REPLACED WITH A NON-EDWARDS DEVICE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE CICU IN STABLE CONDITION.

  Patient problems: Dyspnea

  MAUDE report 23711512 ↗
• InjuryNov 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 7300TFX 29MM MITRAL VALVE WAS EXPLANTED AND REPLACED WITH A 11400M 29MM AFTER AN IMPLANT DURATION OF 4 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. 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 23609656 ↗
• InjuryNov 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT REDO MITRAL VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M MITRIS 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 23500579 ↗
• InjuryOct 18, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS AND FOUR (4) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND DYSPNEA. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 23332803 ↗
• InjuryOct 17, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH HYPOXIC RESPIRATORY FAILURE. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 28MM 9755RSL VALVE. THE PATIENT WAS WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Hypoxia

  MAUDE report 23330974 ↗
• InjuryOct 15, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 7 MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE TMVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL, WAS IN STABLE CONDITION POST PROCEDURE, AND DISCHARGED ON POD #2.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23280163 ↗