CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFX (REF 7300TFX31)Recalls & reported problems

Summary

The FDA's MAUDE database contains 229 adverse event reports that list this exact device (DI 00690103186284), received between May 9, 2018 and May 15, 2026 — classified as 2 deaths, 226 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (98 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 229 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 4 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: Dyspnea; Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 25194514 ↗
• InjuryApr 23, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31 MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31 MM 11400 M 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 24971221 ↗
• InjuryMar 16, 2026Incomplete Coaptation; Insufficient Device Problem Information

  IT WAS REPORTED AND PER INVESTIGATION THAT A PATIENT WITH A 31 MM 7300TFX VALVE IMPLANTED IN THE MITRAL POSITION EXPLANTED AFTER AN IMPLANT DURATION OF 11 YEARS, 9 MONTHS DUE TO INTRAVALVULAR REGURGITATION WITH PROLAPSE LEAFLET. VALVE-IN-VALVE PROCEDURE WAS ATTEMPTED BUT ABORTED DUE TO DISTORTED PATIENT ANATOMY. ADDITIONAL INFORMATION LATER REPORTED THAT THE PATIENT UNDERWENT MITRAL VALVE REPLACEMENT 5 DAYS LATER AT ANOTHER FACILITY, DEVICE IMPLANTED WAS A 33 MM NON-EDWARDS VALVE. PATIENT WAS DISCHARGED TO HOME WITH HOME HEALTH ON POD # 8. PER ADDITIONAL INFORMATION, THERE WAS TEE SHOWED POSTERIOR INTRAVALVULAR REGURGITATION. THERE IS NO PVL OR ROCKING OR DEHISCENCE OF THE VALVE. THE ANTERIOR LEAFLET PROLAPSES INTO LA DURING SYSTOLE WITH LARGE FLAIL GAP.

  Patient problems: Insufficient Information

  MAUDE report 24613211 ↗
• InjuryFeb 20, 2026Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 31MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 11 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 31MM 11400M MITRAL 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: Dyspnea; Insufficient Information

  MAUDE report 24401432 ↗
• 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 23811563 ↗
• InjuryOct 27, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 31MM 7300TFX MITRAL VALVE APPROXIMATELY 9 YEARS, EIGHT (8) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND TRANSVALVULAR REGURGITATION. PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23397472 ↗
• InjuryOct 24, 2025Calcified; Calcified

  PER THE REPORT RECEIVED FROM AUSTRALIA, A 64-YEAR-OLD PATIENT WITH A VALVE MODEL 7300TFX31 IMPLANTED IN MITRAL POSITION UNDERWENT A VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF ONE (1) YEAR AND FIVE (5) MONTHS DUE TO CALCIFIC DEGENERATION LEADING TO SEVERE STENOSIS AND SEVERE REGURGITATION. PRIOR TO THE INTERVENTION, THE PATIENT PRESENTED WITH HEART FAILURE AND WAS CRITICALLY ILL, INTUBATED IN THE INTENSIVE CARE UNIT, AND GIVEN A PROGNOSIS OF 48 HOURS TO LIVE. THE PATIENT EXPERIENCED MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA (VT) ARREST, 8 TO 10, REQUIRING DEFIBRILLATION AND ONE EPISODE NECESSITATING CARDIOPULMONARY RESUSCITATION (CPR) TO RESTORE CARDIAC OUTPUT. A 29MM TRANSCATHETER VALVE WAS URGENTLY DEPLOYED WITHIN THE EDWARDS SURGICAL VALVE DURING A VT ARREST. THE PROCEDURE ENDED SUCCESSFULLY, AND THE PATIENT WAS REPORTED TO BE STABLE AND SLOWLY RECOVERING, WITH NO NEUROLOGICAL EFFECTS NOTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23378990 ↗
• InjurySep 22, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 3 MONTHS DUE TO CALCIFICATION, DEGENERATION, AND SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, DYSPNEA, AND FATIGUE. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL VALVE. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23110141 ↗
• InjurySep 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 31MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT REDO MITRAL VALVE REPLACEMENT AFTER AN APPROXIMATE IMPLANT DURATION OF TWO (2) YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE REPLACEMENT VALVE 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: Insufficient Information

  MAUDE report 23102659 ↗
• InjurySep 19, 2025Calcified; Calcified

  IT WAS REPORTED A PATIENT WITH A 31MM 7300TFX MITRAL VALVE IMPLANTED NINE (9) YEARS, TWO (2) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND CALCIFICATION. PATIENT WAS ASYMPTOMATIC. TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM S3UR TRANSCATHETER VALVE. PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100813 ↗
• InjurySep 16, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX MITRAL VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 3 MONTHS DUE TO THICKENED/CALCIFIED LEAFLETS, RESTRICTED FLOW, STENOSIS WITH MG 11MMHG, AND MILD TO MODERATE CENTRAL REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL VALVE. THE PATIENT WAS STABLE POST-PROCEDURE AND WAS DISCHARGED ON POD #1.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23064064 ↗
• InjurySep 15, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 11 MONTHS DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 23051579 ↗
• InjurySep 9, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, EIGHT (8) MONTHS DUE TO UNKNOWN REASONS. THE TMVR PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

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

  MAUDE report 23000213 ↗
• InjurySep 6, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX IN MITRAL POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS AND 2 MONTHS DUE TO STENOSIS. THE PATIENT WAS PRESENTED WITH SHORTNESS OF BREATH AND EDEMA. THE VALVE WAS REPLACED WITH A 9755RSL 29MM TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Swelling/ Edema

  MAUDE report 22988113 ↗
• InjurySep 5, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED AND PER INVESTIGATION THAT A PATIENT WITH A 31MM 7300TFX MITRAL VALVE HAS BEEN PLACED UNDER EVALUATION/CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 11 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. PATIENT IS SCHEDULED FOR PROCEDURE.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 22986514 ↗
• InjurySep 5, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED AND THROUGH INVESTIGATION, A PATIENT WITH 31MM 7300TFX MITRAL VALVE IMPLANTED SEVEN (7) YEARS, 10 MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, AND ACTIVITY INTOLERANCE. TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22979138 ↗
• InjurySep 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 1 MONTH DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M 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 22936202 ↗
• InjuryAug 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX PERICARDIAL MITRAL VALVE WAS PLACED UNDER EVALUATION FOR VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 22885104 ↗
• InjuryAug 21, 2025Fluid/Blood Leak; Intravalvular regurgitation; Fluid/Blood Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, 11 MONTHS DUE TO CENTRAL AORTIC INSUFFICIENCY. THE TMVR PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT LEFT THE PROCEDURE IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 22861884 ↗
• InjuryAug 18, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS AND 10 MONTHS DUE TO CALCIFICATION. THE VALVE WAS REPLACED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22830632 ↗
• InjuryAug 11, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS AND SEVEN (7) MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22778593 ↗
• InjuryAug 7, 2025Calcified; Calcified

  IT WAS REPORTED THAT A MODEL 7300TFX 31MM MITRAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 6 MONTHS DUE TO CALCIFICATION AND DEGENERATION. THE PATIENT PRESENTED WITH NYHA CLASS 2-3 SYMPTOMS WITH DYSPNEA ON EXERTION, AS WELL AS FATIGUE AND LIGHTHEADEDNESS. A 9755RSL 29MM TRANSCATHETER VALVE WAS IMPLANTED. THE PATIENT WAS STABLE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22735456 ↗
• InjuryAug 5, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX MITRAL VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS AND 5 MONTHS DUE TO SEVERE MITRAL STENOSIS AND MODERATE MITRAL REGURGITATION.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22714028 ↗
• InjuryJul 31, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 31MM 7300TFX VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO CALCIFICATION AND INCREASED HIGH GRADIENT. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE- DYSPNEA. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION AND WAS TRANSFERRED TO RECOVERY POST-OP WITHOUT ISSUE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22682691 ↗
• InjuryJul 28, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 31MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS AND 5 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 33MM 11400M MITRAL VALVE.

  Patient problems: Dyspnea; Fatigue; Insufficient Information

  MAUDE report 22636985 ↗