BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 376905 · Received February 17, 2002

    Report

    Report Number
    MW1024102
    Event Type
    Death
    Date Received
    February 17, 2002
    Date of Event
    December 6, 1999
    Report Date
    February 17, 2002
    Manufacturer
    CRYOLIFE INC
    Product Code
    MIE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED PULMONARY ALLOGRAFT HEART VALVE IN 1999. SHOWED SIGNS OF ILLNESS IN 2000, LATER, DETERMINED IN 4 MONTHS TO BE FUNGAL ENDOCARDITIS. THE PT RECEIVED TWO ADD'L VALVE REPLACEMENTS BETWEEN 3 MONTHS IN 2000. THE FUNGUS WAS NON-RESPONDANT TO SURGICAL INTERVENTION AND ANTI-FUNGAL THERAPY TO INCLUDE AMPHOTERACIN-B, FLUCONAZOLE, ITRACONAZOLE AND VORICONAZOLE. IT WAS DETERMINED IN 2 MONTHS THAT THE PT WAS NO LONGER ELIGIBLE FOR SURGICAL INTERVENTION AND THEREFORE WAS LIMITED TO DRUG THERAPY. THE PT WAS DEEMED TERMINALLY ILL BY ATTENDING CARDIOLOGIST AND INFECTIOUS DISEASE DOCTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PULMONARY ALLOGRAFT HEART VALVE MIE CRYOLIFE INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death| H| L| R