BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 48726 · Received November 12, 1996

    Report

    Report Number
    1039618-1996-00004
    Event Type
    Injury
    Date Received
    November 12, 1996
    Date of Event
    August 28, 1996
    Report Date
    November 12, 1996
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 8/28/96 PT WAS ADMITTED TO HOSPITAL WITH THROMBOCYTOPENIA AND JAUNDICE. CARDIO ECHO REVEALED A LARGE VEGETATION ON THE AORTIC VALVE. ALLOGRAFT #6010024 (IMPLANTED 1/2/96) WAS EXPLANTED WITH A NEW ALLOGRAFT. PT IS IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE Implant TISSUE, HEART VALVE MIE CRYOLIFE, INC. AORTIC HEART VALVE 24489

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R