BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 473308 · Received July 22, 2003

    Report

    Report Number
    2953161-2003-00015
    Event Type
    Injury
    Date Received
    July 22, 2003
    Date of Event
    January 23, 2003
    Report Date
    July 21, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT'S ANATOMY CAUSED SOME CHALLENGES IN THIS PROCEDURE TO IMPLANT THE EBE. HOWEVER, DEPLOYMENT OCCURRED AS PLANNED AND COMPLETION ANGIO SHOWED NO ENDOLEAKS. A PROBLEM WAS EXPERIENCED WITH THE 12 FR SHEATH USED IN THIS PROCEDURE AS IT HAD A STEADY LEAK, WHICH RESULTED IN SIGNIFICANT BLOOD LOSS (1100CC) DURING THE PROCEDURE AND BLOOD TRANSFUSION FOR THIS PT.

    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 0212703-01

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention