BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2903618 · Received January 3, 2013

    Report

    Report Number
    2017233-2013-00004
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 18, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THOMPSON, JACQUELINE AND GLENN BERTING, "ENDOVASCULAR LEAKS: PERIOPERATIVE NURSING IMPLICATIONS". AORN JOURNAL 2009; 89: 839-846.

    Description of Event or Problem · 1

    AN ARTICLE IN THE AORN JOURNAL (89 [MAY 2009] 839-846) ("ENDOVASCULAR LEAKS: PERIOPERATIVE NURSING IMPLICATIONS") PRESENTED CASE STUDIES ON FOUR PTS WHO PRESENTED WITH ENDOLEAK. THIS ARTICLE DESCRIBES A (B)(6) MAN WHO UNDERWENT AN ENDOVASCULAR STENT GRAFT REPAIR OF A 7.5 CM ABDOMINAL AORTIC ANEURYSM. THE PROCEDURE WAS UNEVENTFUL WITH A COMPLETION ANGIOGRAM THAT DEMONSTRATED FULL APPOSITION OF THE GRAFTS, PROXIMAL AND DISTAL SEALS, AND NO ENDOLEAK. AT THE SIX MONTH FOLLOW-UP, AN ABDOMINAL ULTRASOUND DEMONSTRATED RESIDUAL BLOOD FLOW IN THE ANEURYSMAL SAC AND A 0.5 CM INCREASE IN THE DIAMETER OF THE ANEURYSM. A CT SCAN WAS PERFORMED, WHICH IDENTIFIED THE PRESENCE OF AN ENDOLEAK. ON AN UNKNOWN DATE, AN INTERVENTION WAS PERFORMED WHEREBY THE PT WAS TREATED USING A DIRECT PUNCTURE EMBOLIZATION TECHNIQUE. DURING THE INTRA-OPERATIVE ANGIOGRAPHIC RUN, THE SURGEON IDENTIFIED THAT THE LEAK WAS A TYPE II LEAK FROM A LUMBAR ARTERY. "GLUE" WAS PERFORMED TO TREAT THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3526 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R