BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3800922 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01058
    Event Type
    Death
    Date Received
    May 8, 2014
    Date of Event
    May 7, 2009
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE SERIAL NUMBER OF THE DEVICE REMAINS UNKNOWN; THEREFORE, NO DEVICE HISTORY RECORD (DHR) REVIEW CAN BE DONE. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, IT WAS LEARNED THIS ELDERLY MALE PATIENT WAS SIGNIFICANT FOR CORONARY ARTERY DISEASE AND VALVULAR HEART DISEASE. NO OTHER PATIENT INFORMATION IS AVAILABLE. IT HAS BEEN LEARNED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT REMAINS IMPLANTED AND THE PATIENT HAS EXPIRED. NO CAUSE OF DEATH HAS BEEN PROVIDED. THERE HAS BEEN NO INFORMATION THAT INDICATES THE DEVICE CONTRIBUTED TO THE PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: ECHOS WERE ASSESSED BY INDEPENDENT REVIEWER WHO INDICATED PROSTHETIC MITRAL VALVE THICKENING WAS PROGRESSIVE AND ABNORMAL SINCE IMPLANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DATE OF EVENT IS BEING CORRECTED TO (B)(6) 2012. THERE WAS A PROGRESSION OF DISEASE. ON THIS DATE, ECHO REVEALED MITRAL REGURGITATION TO BE SEVERE.

    Description of Event or Problem · 1

    EDWARDS HAS RECEIVED INFORMATION THAT A 25MM MITRAL BIOPROSTHETIC VALVE EXHIBITED A GRADIENT OF 10MMHG (MEAN) AND 21MMHG (PEAK) WITH MODERATE MITRAL REGURGITATION AT ONE (1) MONTH AFTER IMPLANT. AT THREE (3) YEARS, EIGHT (8) MONTHS MITRAL GRADIENT INCREASED TO 14MMHG (MEAN) AND 23MMHG (PEAK) WITH SEVERE MITRAL REGURGITATION. INFORMATION LATER OBTAINED REVEALED THIS 84 YEAR OLD MALE PATIENT EXPIRED APPROXIMATELY 3 YEARS, 10 MONTHS POST-MVR AND CABGX3. PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR CORONARY ARTERY DISEASE AND VALVULAR HEART DISEASE. DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277495 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death