BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOLIFE, INC.

    MDR report key: 333188 · Received May 8, 2001

    Report

    Report Number
    MW1021894
    Event Type
    Injury
    Date Received
    May 8, 2001
    Date of Event
    May 1, 2001
    Report Date
    May 3, 2001
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    LMO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HAD CADAVERIC GREATER SAPHENOUS VEIN ALLOGRAFT USED FOR CONDUIT IN FEM-POST. TIB. A. BYPASS IN 2001. GRAFT THROMBOSED. INTRAARTERIAL THROMBOLYSIS. FOUND 2 RELATIVELY LARGE ANEURYSMS IN GRAFT. REQUIRED RESECTION AND INTERPOSITION GRAFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21089 CRYOLIFE, INC. CADAVERIC GREATER SAPHENOUS ALLOGRAFT LMO CRYOLIFE, INC. * 53590

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R