BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2926280 · Received January 18, 2013

    Report

    Report Number
    2953161-2013-00016
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 2, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXC141000/05271043, PXC141200/058303274 AND PXC201000/05315557.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2009, FOLLOW-UP IMAGING SHOWED EVIDENCE OF A TYPE II ENDOLEAK FROM A LUMBAR ARTERY OR A TYPE III JUNCTIONAL LEAK. IT WAS REPORTED THAT THE ENDOLEAK APPEARS TO BE PROXIMAL TO THE AORTIC BIFURCATION ON THE RIGHT SIDE, BUT THE ORIGIN OF THE ENDOLEAK IS UNKNOWN. ON (B)(6) 2012, A FOLLOW-UP IMAGING AGAIN SHOWED EITHER A TYPE II OR TYPE III ENDOLEAK WITH EVIDENCE OF 1 CM ANEURYSM ENLARGEMENT. NO FURTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28212 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 05007999

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R