BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2132221 · Received June 14, 2011

    Report

    Report Number
    2953161-2011-00139
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 13, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. THE DEVICES WERE PLACED WITHOUT INCIDENT, BUT AFTER THE 12 FR GORE DRYSEAL SHEATH WAS REMOVED, THE COMPLETION ANGIOGRAM SHOWED NO FLOW THROUGH THE LEFT (CONTRALATERAL) EXTERNAL ILIAC ARTERY (EIA). THERE WAS A DISSECTION EXTENDING DISTALLY FROM THE END OF THE CONTRALATERAL LEG ENDOPROSTHESIS. TWO BARE METAL STENTS WERE PLACED IN THE LEFT EIA, EXTENDING TO THE COMMON FEMORAL ARTERY. THE DISSECTION WAS RESOLVED, AND THE PT IS STABLE WITH NO OTHER COMPLICATIONS. ACCORDING TO THE PHYSICIAN, THE DISSECTION WAS DUE TO THE NARROW/CALCIFIED ANATOMY OF THE EIA, AND THE INTIMA WAS LIKELY TORN DURING REMOVAL OF THE SHEATH. IT MAY ALSO HAVE BEEN DUE TO BALLOONING AT THE DISTAL END OF THE CONTRALATERAL LEG WITH A 14 MM ANGIOPLASTY BALLOON (MFR UNK).

    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 8253573

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention NITROSTAT| BOCUSATE| TENORMIN| ASPIRIN| ULTRACIN| ACTONEL| KENALOG| MIRAPEX| ATIVAN| NEURONTIN| PEPCID| BETA| LIPITOR| CAROTENE| ZOLOFT| 3 CORONARY STENTS| DITROPAN