BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROTHESIS

    MDR report key: 3122507 · Received May 15, 2013

    Report

    Report Number
    2017233-2013-00306
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXCLUDER DEVICES INCLUDED IN THIS REPORT: PXC181000/7092814, PXA280300/7075028, PXC121000/06807946, PXA280300/7075029. RESULTS - A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. SPECIFICALLY, THE IFU WARNS THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK AND ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A SYSTEM OF GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED WHAT WAS THOUGHT TO BE A PROXIMAL TYPE I ENDOLEAK. THE PATIENT'S ANEURYSM MEASURED 6.2 X 6.1 CM IN DIAMETER. ON (B)(6) 2013, CT SCAN REVEALED THE SAME ENDOLEAK, WITH THE ANEURYSM MEASURING 6.8 X 6.4 CM IN DIAMETER. ON (B)(6) 2013, AN ANGIOGRAM CONFIRMED A TYPE II ENDOLEAK CONTRIBUTING TO ANEURISMAL ENLARGEMENT. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT, AND DECIDE WHETHER RE-INTERVENTION WILL BE NECESSARY AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215299 GORE EXCLUDER AAA ENDOPROTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 7193597

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other ATORVASTATIN| METOPROLOL| MELOXICAM