BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2161725 · Received July 8, 2011

    Report

    Report Number
    2017233-2011-00332
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 8, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED. PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PT POPULATIONS: MORBIDLY OBESE PTS. THE IFU STATES ADDITIONAL CONSIDERATIONS FOR PT SELECTION INCLUDE BUT ARE NOT LIMITED TO: CO-MORBIDITIES (E.G., CARDIAC, PULMONARY OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011, THE PT WAS COMPLAINING OF LEG PAIN WHILE WALKING. AN ANGIOGRAM REVEALED THAT THE TRUNK-IPSILATERAL LEG COMPONENT COLLAPSED IN BETWEEN THE FLOW DIVIDER AND THE TOP OF THE GRAFT. THE PT WAS IMPLANTED WITH ONE PALMAZ STENT THE SAME DAY TO TREAT THE COLLAPSED PORTION OF THE DEVICE. THE PROCEDURE ENDED WITHOUT FURTHER COMPLICATIONS AND THE PT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE ANGLE OF THE PT'S AORTIC NECK WAS APPROX 60 DEGREES AND WITHIN IFU MEASUREMENTS.

    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 WLG425 8403959

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R ATENOLOL| ASPIRIN| COZAR| ALBUTEROL| QVAR INHALER| CERVENT| CRESTOR