BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1835274 · Received September 10, 2010

    Report

    Report Number
    2953161-2010-00164
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 9, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES RELATED TO THIS EVENT ARE: PXC141400/7619389, PXC210000/8037802, PXC201200/7223454, PXA280300/7556603, PXA280300/06775555, PXA280300/06700903. THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), STATES: THE GORE EXCLUDER AAA ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PATIENTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY AS DESCRIBED BELOW: MINIMUM AORTIC NECK LENGTH OF 15MM.

    Description of Event or Problem · 1

    ON (B)(6), 2010,THE PATIENT UNDERWENT AN EMERGENT PROCEDURE FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND AN AORTIC FISTULA. THERE WAS NO IMAGING PERFORMED PRIOR TO THE PROCEDURE. THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS WITH A TRUNK IPSILATERAL COMPONENT PLACED UP THE RIGHT SIDE, JUST BELOW THE RENAL ARTERY. THE CONTRALATERAL GATE WAS CANNULATED AND A CONTRALATERAL LEG COMPONENT WAS PLACED AND EXTENDED WITH CONTRALATERAL LEG COMPONENTS. THE PHYSICIAN USED A CODA BALLOON TO TACK THE PROXIMAL END OF THE TRUNK COMPONENT, BUT HAD DIFFICULTY OBTAINING WALL APPOSITION. WHEN TACKING WITH THE CODA BALLOON, IT CAUGHT THE PROXIMAL EDGE OF THE TRUNK COMPONENT CAUSING THE DEVICE TO SLIP DOWN INTO THE ANEURYSM SAC. THE TRUNK IPSILATERAL COMPONENT WAS MANEUVERED BACK UP INTO THE AORTIC NECK, AND A GORE EXCLUDER AORTIC EXTENDER COMPONENT WAS PLACED TO BETTER SEAT THE DEVICE AND EXTEND COVERAGE. AN ADDITIONAL AORTIC EXTENDER WAS IMPLANTED PROXIMAL TO THE PREVIOUS IMPLANTED AORTIC EXTENDER TO FURTHER EXTEND COVERAGE. THE CODA BALLOON WAS AGAIN USED TO ANGIOPLASTY AND TACK THE AREA. THE DEVICES AGAIN DROPPED DOWN INTO THE ANEURYSM SAC. THE DEVICES WERE MANEUVERED BACK UP TO THE AORTIC NECK AND RE-ANGIOPLASTIED. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE AREA WAS PERFORMED AND SHOWED A GAP BETWEEN THE TWO EXTENDER COMPONENTS OF APPROXIMATELY 2 MM. A GORE TRI-LOBE BALLOON CATHETER WAS THEN USED TO LESSEN THE GAP BETWEEN THE TWO AORTIC EXTENDER COMPONENTS. THE GAP WAS MUCH IMPROVED. AN ADDITIONAL AORTIC EXTENDER COMPONENT WAS IMPLANTED TO EXTEND PROXIMAL COVERAGE AND THE RENAL ARTERIES WERE COVERED. THE SUPERIOR MESENTERIC ARTERY (SMA) WAS WIDELY PATENT. A COOK ZENITH CUFF WAS PLACED TO OVERLAP THE SMALL GAP THAT REMAINED BETWEEN THE TWO AORTIC EXTENDER COMPONENTS, AND THE PHYSICIAN THEN PERFORMED AN AORTO-UNI-ILIAC (AUI) AND FEMORAL BYPASS ON THE RIGHT SIDE WITH MULTIPLE COOK TUBULAR GRAFTS. THE PATIENT TOLERATED THE PROCEDURE.

    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 WLG325 7783331

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O