BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2121441 · Received May 6, 2011

    Report

    Report Number
    2953161-2011-00111
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MFG RECORDS IS BEING CONDUCTED. THE DELIVERY CATHETER HAS BEEN RETURNED TO GORE AND AN EVAL IS UNDERWAY.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PT WAS IMPLANTED WITH A MEDTRONIC ENDURANT STENT GRAFT. THE PHYSICIAN DECIDED TO USE A GORE EXCLUDER AAA ENDOPROSTHESIS TO EXTEND THE ENDURANT GRAFT. A COOK 16FR SHEATH WAS INSERTED BUT WOULD NOT ADVANCE INTO THE DISTAL PORTION OF THE ENDURANT LIMB. THE EXCLUDER DEVICE WAS ADVANCED WITHOUT A SHEATH AND THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING PAST THE DISTAL END OF THE ENDURANT LIMB. THE EXCLUDER DEVICE WAS EVENTFULLY ADVANCED THROUGH THE ENDURANT LIMB WITH 2-3 CM OF OVERLAP BUT THE DEVICE STARTED TO SELF DEPLOY. DEPLOYMENT WAS COMPLETED USING THE DEPLOYMENT LINE AND IT WAS THEN NOTICED THAT THE OLIVE OF THE DELIVERY CATHETER HAD BROKEN. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE OLIVE FROM THE PT. THE PT TOLERATED THE PROCEDURE AND IS REPORTED TO BE DOING FINE. THE DELIVERY CATHETER WAS RETURNED TO GORE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. WLG425 7715565

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R