BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 473560 · Received July 22, 2003

    Report

    Report Number
    2953161-2003-00020
    Event Type
    Injury
    Date Received
    July 22, 2003
    Date of Event
    February 17, 2003
    Report Date
    July 22, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EBE DEPLOYED IN PATIENT SUCCESSFULLY, HOWEVER, PATIENT LOST PULSE TO LEFT FOOT AND SURGEON HAD TO PERFORM AN ILEO-TO-FEMORAL BYPASS AND AN EMBOLECTOMY. THE PATIENT'S PULSE WAS RESTORED. THIS EVENT WAS NOT SPECIFICALLY A CAUSE OF THE EBE, BUT RATHER RELATED TO THIS ENDO-VASCULAR PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention