BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 174291 · Received June 24, 1998

    Report

    Report Number
    1063481-1998-00001
    Event Type
    Injury
    Date Received
    June 24, 1998
    Date of Event
    May 4, 1998
    Report Date
    May 15, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    5 YR OLD MALE STATUS POST RASTELLI USING AV00 ON 6/23/1994. ON 5/4/1998, UNDERWENT CONDUIT REPLACEMENT AND VENTRICULAR SEPTAL DEFECT CLOSURE. SURGEON NOTED THAT PREVIOUS VALVE HAD BECOME STENOTIC, POSSESSED CUSP DEGENERATION, AND WAS GROSSLY CALCIFIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R