BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2879023 · Received December 11, 2012

    Report

    Report Number
    2017233-2012-00825
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 13, 2012
    Report Date
    December 5, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THESE DEVICES IS IN PROCESS. ENDOGRAFT, DURING THE REINTERVENTION, WHILE ADVANCING A GORE PXA DEVICE, IT MET RESISTANCE AT THE CROSSOVER POINT OF THE ILIAC LIMB AND COULD NOT BE ADVANCED DESPITE VARIOUS MANIPULATIONS. ATTEMPTS TO RECAPTURE THE DEVICE IN THE SHEATH WERE ALSO UNSUCCESSFUL. AFTER SEVERAL ATTEMPTS, THE DEVICE WAS DEPLOYED IN THE RIGHT ILIAC LIMB OF THE PREVIOUSLY PLACED ENDOGRAFT WITH GOOD EXPANSION. THE SECOND ATTEMPT TO DEPLOY A GORE PXA DEVICE JUST DISTAL TO THE RENALS WAS ATTEMPTED; THIS DEVICE WAS DEPLOYED AND THEN SLIPPED DISTALLY BEFORE THE PHYSICIAN COULD DILATE WITH THE BALLOON. IT WAS FULLY EXPANDED IN THE PROXIMAL SEGMENT OF THE PREVIOUS ENDOGRAFT. AT THIS POINT, THE PHYSICIAN CHOSE TO GAIN ACCESS THROUGH THE LEFT BRACHIAL ARTERY. A .014 BALLOON WAS INFLATED IN THE LEFT RENAL ARTERY TO PROTECT THE LEFT RENAL ARTERY ORIGIN. A THIRD GORE PXA DEVICE WAS DEPLOYED JUST DISTAL TO THE RENAL ARTERY. THE DEVICE WAS POST DILATED WITH A Q50 BALLOON IN SEVERAL LOCATIONS; DISTAL, MID, AND PROXIMAL. THE GORE PXA DEVICE WOULD NOT CONFORM TO THE LEFT LATERAL AORTIC WALL UNDER THE LEFT RENAL ARTERY DESPITE GOOD POSITION JUST INFERIOR TO THE LEFT RENAL ARTERY. THERE IS STILL A PROXIMAL SEGMENT OF ANEURYSM ON THE LEFT SIDE OF THE AORTA WHICH IS INADEQUATELY OCCLUDED BECAUSE THE GORE DEVICE DOES NOT EXPAND TO CONTACT THE WALL OF THE LEFT SIDE OF THE AORTA. THE PT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM IN TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012, COMPUTERIZED TOMOGRAPHY (CT) SHOWED THAT THE DEVICE MIGRATED DISTALLY BY 1 CM. THIS RESULTED IN A PROXIMAL TYPE I ENDOLEAK. THE ANEURYSM SHRUNK BY .4MM. THE REASON FOR THE DEVICE MIGRATION COULD NOT BE DETERMINED. ON (B)(6) 2012, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENTS. IT WAS REPORTED THAT THE PT HAS A HIGHLY ANGULATED ABDOMINAL AORTA JUST BELOW THE LEFT RENTAL ARTERY, CAUSING AN UNCOVERED SEGMENT OF APPROX 1.2CM FROM THE PROXIMAL EDGE OF THE PREVIOUSLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554689 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8883134

    Patients

    Seq Age Sex Outcome Treatment
    1