BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 515725 · Received March 11, 2004

    Report

    Report Number
    2953161-2004-00011
    Event Type
    Death
    Date Received
    March 11, 2004
    Date of Event
    February 10, 2004
    Report Date
    March 11, 2004
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE TRUNK-IPSILATERAL COMPONENT OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS WAS SUCCESSFULLY DEPLOYED. THE CONTRA-LATERAL LEG HOLE STUMP RESTED IN THE SACULAR ANEURYSM ON A SHELF, MAKING IT IMPOSSIBLE FOR THE PHYSICIAN TO GAIN ACCESS TO THE GATE WITH THE GUIDE WIRE, DESPITE TRYING TO GO UP AND OVER AND SNARE THE WIRE. THE CASE WAS CONVERTED TO AN AORTO-UNI-ILIAC APPROACH. A SECOND TRUNK-IPSILATERAL DEVICE WAS DEPLOYED WITHOUT INCIDENT. FINAL ANGIO REVEALED A TYPE I ENDOLEAK. DESPITE NUMEROUS BALLOONING ATTEMPTS THE ENDOLEAK REMAINED. THE PHYSICIAN DECIDED TO CONVERT THE PT TO OPEN SURGICAL REPAIR OF THE ABDOMINAL AORTIC ANEURYSM. DURING THE OPEN PROCEDURE, THE AORTA RUPTURED AND THE PT LATER EXPIRED.

    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 0327304-16

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death