BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 473710 · Received July 23, 2003

    Report

    Report Number
    2953161-2003-00023
    Event Type
    Injury
    Date Received
    July 23, 2003
    Date of Event
    April 10, 2003
    Report Date
    July 23, 2003
    Manufacturer
    WLGORE & ASSOC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THIS PROCEDURE TO PLACE THE ENDOVASCULAR GRAFT SYSTEM, DIFFICULTY WAS EXPERIENCED IN CANNULATING THE CONTRALATERAL LEG HOLE OF THE TRUNK-IPSILATERAL COMPONENT (EBE). 17000U OF IV HEPARIN WAS ADMINISTERED AND THE ADDITIONAL PROCEDURE TIME CONTRIBUTE TO BLOOD LOSS REQUIREING A TRANSFUSION OF BLOOD TO THE PT OF 2000CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLUDER BIFURCATED ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH WLGORE & ASSOC WLG325 0212001-06

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention