BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3170434 · Received June 10, 2013

    Report

    Report Number
    2017233-2013-00364
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THAT FOLLOW-UP CT SCANS TAKEN ON (B)(6) 2012, (B)(6) 2012, AND (B)(6) 2013 HAVE SHOWN THAT THE PROXIMAL SEAL OF THE EXCLUDER DEVICE HAS CONTINUED TO MIGRATE DISTALLY (DISTANCE UNK). ACCORDING TO THE PHYSICIAN, THE ANEURYSM CONTINUES TO SHRINK WITHOUT EVIDENCE OF ENDOLEAK. THE PATIENT IS CURRENTLY DOING WELL; HOWEVER, THE PHYSICIAN PLANS TO INTERVENE IMPLANTING AN AORTIC EXTENDER COMPONENT PROXIMALLY TO EXTEND TO THE LOWEST RENAL ARTERY. THE INTERVENTION HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261592 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 9693656

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other