BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3955554 · Received July 24, 2014

    Report

    Report Number
    2017233-2014-00371
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 17, 2014
    Report Date
    September 3, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON OR ABOUT (B)(6) 2014, A PERSISTENT ENDOLEAK OF UNKNOWN ORIGIN WAS DETECTED, ALONG WITH ANEURYSMAL SAC EXPANSION. AFTER FURTHER EXAMINATION THE ENDOLEAK APPEARS TO BE A TYPE 1A. THE PATIENT WILL REQUIRE A REINTERVENTION WITH A FENESTRATED SUPER RENAL GRAFT. AS LOT/SERIAL NUMBER IS UNKNOWN, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433904 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R