BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 1009094 · Received March 5, 2008

    Report

    Report Number
    1063481-2008-00006
    Event Type
    Other
    Date Received
    March 5, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 2008
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ADD'L INFO WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE ALLOGRAFT WAS DAMAGED WHILE IN THE FROZEN STATE. THE SAMPLE WAS RETURNED TO CRYOLIFE, INC. AND WAS OBSERVED TO BE TRANSECTED PROXIMAL TO THE BIFURCATION. THERE WERE TWO CRACKS IN THE MUSCLE BAND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other