BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3212757 · Received July 1, 2013

    Report

    Report Number
    2953161-2013-00095
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. IN (B)(6) 2013 (DATE UNK), FOLLOW-UP IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK WITH NO VISIBLE MIGRATION OF THE DEVICES. IT WAS REPORTED THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS REMODELING OF THE ANEURYSM SAC. NO ANEURYSM GROWTH WAS REPORTED. ON 06/19/2013, AN INTERVENTION WAS PERFORMED TO TREAT THE PROXIMAL TYPE I ENDOLEAK. AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO PROVIDE 4-5 MM OF PROXIMAL EXTENSION UP TO THE RENAL ARTERIES. ADDITIONALLY, SEVEN APTUS SCREWS WERE IMPLANTED TO SECURE THE AORTIC EXTENDER COMPONENT IN PLACE. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE PROXIMAL TYPE I ENDOLEAK, AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299508 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 06477189

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R TRAZODONE| SIMVASTATIN