BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2800346 · Received October 11, 2012

    Report

    Report Number
    2017233-2012-00709
    Event Type
    Death
    Date Received
    October 11, 2012
    Date of Event
    December 1, 2011
    Report Date
    September 17, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURAN, C. ET. AL. (2012). A LONGITUDINAL VIEW OF IMPROVED MANAGEMENT STRATEGIES AND OUTCOMES AFTER LATROGENIC ILIAC ARTERY RUPTURE DURING ENDOVASCULAR ANEURYSM REPAIR. ANIMALS OF VASCULAR SURGERY, IN PRESS, 1-7.

    Description of Event or Problem · 1

    AN ARTICLE BY DURAN, ET AL. (2012), REPORTED THE INCIDENCE OF INTRAOPERATIVE ILIAC ARTERY RUPTURES IN A RETROSPECTIVE REVIEW OF ENDOVASCULAR ANEURYSM REPAIRS FROM (B)(6) 1997 THROUGH (B)(6) 2011. TWENTY PTS IN THE STUDY HAD RUPTURES. OF THESE, FOUR HAD BEEN TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. IN THE TWENTY PTS, SIXTEEN OF THE RUPTURES WERE IN A COMMON ILIAC ARTERY AND FOUR IN AN EXTERNAL ILIAC. ALL RUPTURES WERE CONFIRMED INTRAOPERATIVELY BY ANGIOGRAPHY AND CONTRAST EXTRAVASATION. THE ILIAC RUPTURES OCCURRED DURING ONE OF FOUR PROCEDURAL MANEUVERS: DEVICE INSERTION (12), BALLOON ANGIOPLASTY AFTER FAILED INITIAL ACCESS (FOUR), BALLOONING OF A TYPE IB ENDOLEAK (TWO), AND BALLOON MOLDING OF THE GRAFT AGAINST A NONCOMPLIANT ARTERIAL WALL. THE RUPTURES WERE TREATED WITH OPEN OR ENDOVASCULAR REPAIR. THERE WERE NO INTRAOPERATIVE DEATHS. FOUR PTS EXPIRED WITHIN THE FIRST THREE DAYS POST-OPERATIVELY, AND ALL FOUR PTS HAD UNPLANNED BILATERAL OCCLUSION OF THEIR HYPOGASTRIC ARTERIES. ALL DIED FROM COMPLICATIONS OF PELVIC ISCHEMIA AND/OR MULTIORGAN SYSTEM FAILURE. THERE WAS ONE OTHER DEATH WITHIN 30 DAYS FROM A CARDIAC EVENT. EXCLUDING THE EARLY DEATHS, EIGHT OF 16 SURVIVING PTS DEVELOPED POSTOPERATIVE COMPLICATIONS, WHICH INCLUDED ABDOMINAL WOUND INFECTION (ONE), WOUND DEHISCENCE (ONE), STROKE (ONE), POSTOPERATIVE MYOCARDIAL INFARCTION (TWO), PNEUMONIA (TWO), LINE BACTEREMIA (ONE), AND ACUTE RENAL FAILURE (ONE).

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| L| R