BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOLIFE HEART VALVE

    MDR report key: 414768 · Received September 9, 2002

    Report

    Report Number
    MW1026064
    Event Type
    Death
    Date Received
    September 9, 2002
    Date of Event
    May 1, 1998
    Report Date
    September 6, 2002
    Manufacturer
    *
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT DIED 5 MONTHS AFTER RECEIVING A HEART VALVE TRANSPLANT AT HOSPITAL IN ANOTHER CITY. PT DIED AT LOCAL HOSPITAL. THE CAUSE OF DEATH WAS RULED "HEART ATTACK", DUE TO THEIR HEART CONDITION. AFTER RECEIVING VALVE, PT HAD SOME PARALYSIS ON THE RIGHT SIDE, BUT FAMILY WAS TOLD NOT TO WORRY ABOUT IT. PT HAD PHYSICAL AND OCCUPATIONAL THERAPY, INCLUDING SPEECH UNTIL THE TIME OF DEATH. FAMILY IS CONCERNED PT MAY HAVE RECEIVED A VALVE FROM THIS COMPANY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 01/10/03: ACCORDING TO TELEPHONE CONVERSATIONS WITH THE IMPLANTING SURGEON'S OFFICE, PLEASE NOTE THAT THIS EVENT IS NOT ASSOCIATED WITH AN ALLOGRAFT PROCESSED AND DISTRIBUTED BY CRYOLIFE, INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death