BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2232615 · Received August 26, 2011

    Report

    Report Number
    2953161-2011-00183
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 25, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. A REVIEW OF THE MFG RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE EXCLUDER AAA ENDOPROSTHESIS SPECIFIES: GORE RECOMMENDS THAT THE GORE EXCLUDER AAA ENDOPROSTHESIS DIAMETER BE AT LEAST 2 MM LARGER THAN THE AORTIC INNER DIAMETER (10 - 21% OVERSIZING) AND 1 MM LARGER THAN THE ILIAC INNER DIAMETER (7 - 25% OVERSIZING). THE INTENDED AORTIC VESSEL DIAMETER FOR THE DEVICE IMPLANTED IS 24MM - 26MM AND THE INTENDED ILIAC VESSEL DIAMETER IS 12MM - 13.5 MM. ADDITIONALLY, THE IFU STATES: ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK, ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2011, A CONTROL COMPUTED TOMOGRAPHY (CT) WAS PERFORMED ON THE PT THAT SHOWED CONTRAST IN THE ANEURYSM SAC, AND ENLARGEMENT OF THE ANEURYSM BY APPROX 9 MM. THE PHYSICIAN SUSPECTS A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011, THE PT UNDERWENT A RE-INTERVENTION. A GORE AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY AND EXTENDED WITH A PALMAZ STENT. THE PALMAZ STENT WAS LANDED PARTIALLY ABOVE THE RENAL ARTERIES. THERE WAS NO OBSTRUCTION OF FLOW TO THE RENAL ARTERIES. FINAL CONTROL ANGIOGRAPHY WAS UNABLE TO DETERMINE IF THE ENDOLEAK WAS RESOLVED. THE PT TOLERATED THE PROCEDURE. THE PT'S PROXIMAL AORTIC NECK DIAMETER RANGED 23MM - 27MM. THE RIGHT COMMON ILIAC DIAMETER RANGE WAS 12MM - 9MM, AND THE LEFT COMMON ILIAC DIAMETER RANGE WAS 11 MM - 9MM. THE COMPUTED TOMOGRAPHY (CT) IMAGES WERE PROVIDED TO GORE AND AN EVAL WAS PERFORMED. THE MAXIMUM ANEURISMAL DIAMETER MEASURED 88 X 94 MM. THERE WAS NO PROXIMAL WALL APPOSITION. CONTRAST POOLING WAS VISIBLE WHICH APPEARED TO COMMUNICATE WITH THE ANEURYSM SAC, CONFIRMING A TYPE I ENDOLEAK.

    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 WLG425 8724549

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O| R