BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 473590 · Received July 23, 2003

    Report

    Report Number
    2953161-2003-00025
    Event Type
    Injury
    Date Received
    July 23, 2003
    Date of Event
    May 5, 2003
    Report Date
    July 23, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING DEPLOYMENT OF THE TRUNK-IPSILATERAL COMPONENT OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE), CANNULATION OF THE CONTRALATERAL LEG HOLE BEGAN. DURING THIS PROCESS, THE VASCULAR ACCESS CONDUIT CLAMP OPENED, AND SHEATH ACCESS WAS LOST. THIS LED TO EXCESSIVE BLOOD LOSS. THE PATIENT RECEIVED A TRANSFUSION AS WELL AS BLOOD RETURN VIA CELL SAVER. EBE PLACEMENT WAS COMPLETED SUCCESSFULLY. THIS EVENT WAS RELATED TO VASCULAR ACCESS ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLUDER BIFURCATED ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES,INC WLG325 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention