CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS 7000TFX (REF 7000TFX25)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103167849), received between Mar 22, 2021 and Dec 3, 2021 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Gradient Increase” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7000TFX PERICARDIAL VALVE, IMPLANTED IN THE MITRAL POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 12 YEARS, THREE (3) MONTHS DUE TO UNKNOWN REASONS. THE TMVR WAS PERFORMED SUCCESSFULLY WITH A 26MM 9750TFX TRANSCATHETER VALVE WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12927869 ↗
• InjuryJul 29, 2021Gradient Increase; Perivalvular Leak; Gradient Increase; Perivalvular Leak

  IT WAS REPORTED THAT A PATIENT WITH A 25MM EDWARDS PERICARDIAL VALVE, IMPLANTED IN THE MITRAL POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO STENOSIS AND PARAVALVULAR LEAK. THE TMVR WAS PERFORMED SUCCESSFULLY WITH A 26MM 9750TFX TRANSCATHETER VALVE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12250451 ↗
• InjuryApr 16, 2021Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7000TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF 10 YEARS, (3) MONTHS DUE TO STENOSIS. THE TMVR WAS PERFORMED WITH A 26MM 9750TFX.

  Patient problems: Insufficient Information

  MAUDE report 11680342 ↗
• DeathApr 9, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7000TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, TWO (2) MONTHS DUE TO STENOSIS AND REGURGITATION. PER THE MEDICAL RECORDS, THE PATIENT PRESENTED WITH NYHA CLASS IV HEART FAILURE. THE TMVR WAS PERFORMED WITH A 26MM 9600TFX. THE PATIENT WAS TRANSFERRED TO THE CICU IN CRITICAL CONDITION. ON POD #1, THE PATIENT WAS AWAKE AND ALERT AND BECAME ALTERED, PEA ARREST, CODED, AND EXPIRED. THE FINAL PRIMARY DIAGNOSIS WERE LISTED AS; ACUTE HEART AND RENAL FAILURE, AND CARDIOGENIC SHOCK.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11642956 ↗
• InjuryMar 22, 2021Calcified; Degraded; Fluid/Blood Leak; Gradient Increase; Calcified; Degraded; Fluid/Blood Leak; Gradient Increase

  THROUGH IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A 25MM 7000TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS DUE TO CALCIFICATION, STRUCTURAL DETERIORATION, SEVERE MITRAL STENOSIS AND SEVERE MITRAL REGURGITATION [(B)(4). ]. DURING THE REDO MVR PROCEDURE, A 27MM 7300TFX MITRAL VALVE WAS EXPLANTED AT IMPLANT DUE TO OVER SIZING LEADING TO LVOT OBSTRUCTION. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 7300TFX MITRAL VALVE. A TV REPAIR WAS ALSO PERFORMED WITH A 26MM EDWARDS ANNULOPLASTY RING. PER THE MEDICAL RECORDS: THE PATIENT PRESENTED WITH PROGRESSIVE DYSPHAGIA, HOARSE VOICE, SOB, AND FATIGUE. SHE WAS FOUND TO BE IN A-FIB WITH RVR WITH NEW DIAGNOSIS OF ACUTE SYSTOLIC HF. ECHOCARDIOGRAM DEMONSTRATED SEVERE MS AND SEVERE MR AND TEE WAS NOTABLE FOR LARGE THROMBI IN THE LA WITH THE PROSTHETIC VALVE PROTRUDING INTO THE LVOT RESULTING IN OBSTRUCTION. UPON REDO SURGERY, A SUBSTANTIAL AMOUNT OF CLOT WAS OBSERVED IN THE LA AND A LARGE AMOUNT OF CLOT WAS FOUND IN THE PERIVALVULAR AREA OF THE PROSTHESIS. ONCE ALL CLOTS WERE DEBRIDED, THE OLD 25MM MITRAL PROSTHESIS WAS REMOVED. THE PROSTHESIS WAS CALCIFIED AND HAD CLEAR EVIDENCE OF STRUCTURAL DAMAGE. THE MITRAL

  Patient problems: Calcium Deposits/Calcification; Cardiogenic Shock; Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 11545941 ↗