BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3231970 · Received July 3, 2013

    Report

    Report Number
    2017233-2013-00435
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 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

    RESULT: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSION: ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES ADVERSE EVENTS THAT MAY OCCUR AND REQUIRE INTERVENTION INCLUDE ENDOPROSTHESIS - COMPONENT MIGRATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PT'S AORTIC NECK ANGLE WAS AT 40 DEGREES AND THERE WAS SIGNIFICANT THROMBUS IN THE AORTIC NECK. IT WAS REPORTED THAT ON (B)(6) 2013, THE PT UNDERWENT A REOPERATION TO TREAT DISTAL MIGRATION OF THE PXT311413/06574079 DEVICE OF 10 CM PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306505 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06574079

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention