BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3203719 · Received June 25, 2013

    Report

    Report Number
    2953161-2013-00094
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: RMT261416/11197773. THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PT HAD A REPORTED 2 - 2.5 CM OF STRAIGHT AORTIC NECK AREA BELOW THE RIGHT RENAL ARTERY, THE RMT WAS IMPLANTED APPROXIMATELY 1 CM BELOW THE RIGHT RENAL ARTERY, AND THE ANGULATED AORTIC NECK WAS APPROXIMATELY 60 - 70 DEGREES. IT WAS REPORTED THAT AFTER ALL DEVICES WERE IMPLANTED AND BALLOONED THE FINAL ANGIOGRAPH RUN SHOWED A PROXIMAL TYPE I ENDOLEAK (SLIGHT BLUSH). THE PHYSICIAN CHOSE TO IMPLANT A PXA280300/9198179 AORTIC EXTENDER ENDOPROSTHESIS, THIS RESOLVED THE ENDOLEAK. THE FINAL ANGIOGRAPH COMPLETION REVEALED GOOD PLACEMENT AND NO ENDOLEAK. THE PT TOLERATED THE PROCEDURE. APPROXIMATELY SEVEN HOURS POST PROCEDURE, THE PHYSICIAN NOTICED THE PT WAS NOT MAKING URINE. IMAGES REVEALED THAT BOTH RENAL ARTERIES WERE COVERED BY THE AORTIC EXTENDER ENDOPROSTHESIS. THE PHYSICIAN CHOSE TO INTERVENE (WHAT TYPE OF PROCEDURE IS NOT KNOWN), HOWEVER ALL ATTEMPTS TO GET RENAL PROFUSION WERE UNSUCCESSFUL. THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH AND THE PT TOLERATED THE REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288080 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 9198179

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention