BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1780765 · Received July 26, 2010

    Report

    Report Number
    2017233-2010-00349
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 26, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET PRE-RELEASE SPECIFICATIONS. OTHER DEVICES IMPLANTED DURING ORIGINAL PROCEDURE: PXT311415/06675811, PXC201000/06589660, PXC201200/6978408, PXA230300/06704085.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2010, A REINTERVENTION OCCURRED WHEREBY THE PHYSICIAN PLACED AN AORTIC EXTENDER COMPONENT IN THE PREVIOUSLY IMPLANTED CONTRALATERAL LEG COMPONENT TO TREAT A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN PLACED COILS AROUND THE CONTRALATERAL LEG COMPONENT AND ALSO IN SURROUNDING LUMBAR ARTERIES. POST PROCEDURE, A SMALL ENDOLEAK REMAINED, BUT THE PHYSICIAN BELIEVES THAT THE ENDOLEAK WILL THROMBOSE IN TIME.

    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 7058421

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R COUMADIN