BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1972231 · Received January 21, 2011

    Report

    Report Number
    2017233-2011-00033
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 20, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEWED OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. AN IMAGING EVAL WAS CONDUCTED. PER GORE IMAGING SERVICES, THE ORIGIN OF ENDOLEAK ON IMAGES DATED (B)(6) 2010 COULD NOT BE DETERMINED. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, TYPE II ENDOLEAKS ARE A KNOWN RISK FACTOR FOR ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. PLEASE NOTE ADD'L DEVICES IMPLANTED: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2010, CT SHOWED AN UNSPECIFIED ENDOLEAK. ON (B)(6) 2011, THE PT UNDERWENT AN INTERVENTION WHERE THREE TYPE II ENDOLEAKS WERE IDENTIFIED AND COILED. THE ENDOLEAKS WERE RESOLVED. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG425 6979064

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R (B)(4)| ASPIRIN