BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3600451 · Received January 15, 2014

    Report

    Report Number
    2953161-2014-00005
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    October 24, 2013
    Report Date
    December 17, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES, FLAGSTAFF, AZ
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXC201000/8851900, PXA260300/7240853, PXC161000/7244791, AND PXA230300/8420795.

    Description of Event or Problem · 1

    ON (B)(6)2011, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2013, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED ANEURYSM GROWTH (AMOUNT UNKNOWN) AND CONTRAST IN A LUMBAR ARTERY AND INFERIOR MESENTERIC ARTERY (IMA). ON (B)(6) 2013, THE PATIENT UNDERWENT A REINTERVENTION TO EXPLANT THE GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED A TYPE II ENDOLEAK FROM A LUMBAR ARTERY AND IMA APPEARED TO BE FEEDING INTO THE ANEURYSM SAC. THE DEVICES WERE EXPLANTED AND THE ANEURYSM WAS REPAIRED WITH A SURGICAL GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37981 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES, FLAGSTAFF, AZ 8478233

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R LASARTIC| FISH OIL| WARFARIN| IRON| MONTELUKAST| ALLOPURINOL| LIPITOR| HYDROCHLOROTHIAZIDE| ASPIRIN