BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1760144 · Received July 12, 2010

    Report

    Report Number
    2017233-2010-00326
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 11, 2007
    Report Date
    July 8, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2007, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNK DATE, COMPUTED TOMOGRAPHY SHOWED INFOLDING IN THE DISTAL PORTION OF THE GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT, WHICH HAD BEEN IMPLANTED ON THE LEFT SIDE. THE PT IS PRESENTLY ASYMPTOMATIC. THE PHYSICIAN IS PLANNING A REINTERVENTION WHERE HE WILL RE-BALLOON THE INFOLDED PORTION OF THE GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG. MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO ON THIS EVENT HAVE BEEN MADE BY GORE, HOWEVER, AS OF (B)(6) 2010, NO FURTHER INFO ON THIS PT HAS BEEN PROVIDED TO GORE.

    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 05058538

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other