BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 449543 · Received March 21, 2003

    Report

    Report Number
    1063481-2003-00066
    Event Type
    Other
    Date Received
    March 21, 2003
    Date of Event
    February 19, 2003
    Report Date
    February 19, 2003
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 1996, THE CYOPRESERVED MITRAL VALVE WAS IMPLANTED INTO A PATIENT DURING A SURGICAL PROCEDURE OF UNKNOWN TYPE. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. APPROXIMATELY 7 YEARS AFTER IMPLANT, THE MITRAL VALVE WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL DETAIL HAS BEEN REQUESTED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE HEART VALVE ALLOGRAFT MIE CRYOLIFE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| L| R