BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3131035 · Received May 21, 2013

    Report

    Report Number
    2017233-2013-00316
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 23, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED WITH THE PROVIDED INFO. ADD'L DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2013, A COMPUTED TOMOGRAPHY SCAN IDENTIFIED ANEURYSM GROWTH FROM 5.1 X 4.8 CM TO 7.1 X 6.5 CM WITH AN UNDETERMINED ENDOLEAK. IT WAS REPORTED THE CAUSE OF THE ENDOLEAK IS UNK, AND IT IS UNK WHICH DEVICE WAS ASSOCIATED WITH THE ENDOLEAK. NO FURTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225535 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 6994301

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R COUMADIN| DIOVAN