BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2122955 · Received June 3, 2011

    Report

    Report Number
    2017233-2011-00262
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    January 19, 2011
    Report Date
    June 2, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2011, AN INTERVENTION OCCURRED. THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA AORTIC EXTENDER ENDOPROSTHESIS TO REPAIR A PROXIMAL TYPE-1 ENDOLEAK. THE TYPE-1 ENDOLEAK WAS RESOLVED BUT A SMALL TYPE-2 ENDOLEAK WAS IDENTIFIED UPON COMPLETION. THE PT TOLERATED THE PROCEDURE WELL. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    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 06865501

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R SULFASALAZINE| CALCIUM| IRON| PEPCID| LOPRESSOR| MULTI-VITAMINS