BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 487286 · Received October 3, 2003

    Report

    Report Number
    1063481-2003-00085
    Event Type
    Other
    Date Received
    October 3, 2003
    Date of Event
    August 18, 2003
    Report Date
    September 2, 2003
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2001, THE CRYOPRESERVED AORTIC VALVE AND CONDUIT WAS IMPLANTED. IN 2003 THE SECOND HOMOGRAFT WAS SUBSEQUENTLY EXPLANTED SECONDARY TO CALCIFICATION, STENOSIS AND INSUFFICIENCY.

    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 3 YR Hospitalization| L| O| R