BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2926184 · Received January 15, 2013

    Report

    Report Number
    2017233-2013-00021
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    April 1, 2011
    Report Date
    December 19, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    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 DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PXC181000/05870611 AND PXC201400/06236660. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. 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, ANEURYSM ENLARGEMENT, AND SURGICAL CONVERSION.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THIS PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011, THE THREE EXCLUDER DEVICES WERE EXPLANTED. IT WAS REPORTED THE ENDO STENT WAS LEAKING AND CAUSING PROGRESSIVE ENLARGEMENT OF THE ABDOMINAL AORTA. THE PHYSICIAN PERFORMED AN OPEN CONVERSION AND THEN DID AN ILIAC BYPASS. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21884 GORE EXCLUDER AAA ENDOPROSTHESIS * MIH W.L. GORE & ASSOCIATES 06194318

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention HYDROCHLOROTHIAZIDE| METFORMIN| LOTREL| SIMVASTATIN| METOPROLOL