BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3143087 · Received May 29, 2013

    Report

    Report Number
    2017233-2013-00344
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO IMPROPER COMPONENT PLACEMENT, RENAL ARTERY OCCLUSION, AND SURGICAL CONVERSION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH A SYSTEM OF GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. PRIOR TO DEVICE IMPLANTATION, CORRECT POSITIONING WAS REPORTEDLY VERIFIED ANGIOGRAPHICALLY BY THE PHYSICIAN AND ASSISTANTS. AFTER THREE EXCLUDER DEVICE COMPONENTS HAD BEEN IMPLANTED, AN ANGIOGRAPHIC RUN REVEALED THAT THE TRUNK-IPSILATERAL LEG COMPONENT WAS LANDED 1 CM ABOVE ITS INTENDED TARGET. THE LEFT RENAL ARTERY WAS COVERED WHILE THE RIGHT RENAL ARTERY REMAINED PATENT. THE PHYSICIAN DECIDED TO CONVERT TO AN OPEN PROCEDURE AND PERFORM A RIGHT COMMON ILIAC TO LEFT RENAL ARTERY BYPASS. THE IMPLANTED EXCLUDER DEVICES WERE LEFT IN PLACE. BLOOD FLOW WAS RESTORED TO THE LEFT RENAL ARTERY AND THE ANEURYSM WAS SUCCESSFULLY EXCLUDED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236953 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8321735

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other METOPROLOL| CAPTOPRIL| FUROSEMIDE| ECOTRIN| OCUVITE| LIPITOR| ALLOPURINOL