BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2132219 · Received June 14, 2011

    Report

    Report Number
    2017233-2011-00276
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 13, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASEE SPECIFICATIONS. CONCLUSIONS - AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN PTS WITH PROXIMAL AORTIC NECK ANGULATIONS EXCEEDING 60 DEGREES. COMPLICATIONS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM. THE AORTIC NECK WAS HIGHLY ANGLED, MEASURING ABOUT 70 DEGREES. COMPLETION ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK. THE PT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2011, AN INTERVENTION OCCURRED TO TREAT A PROXIMAL TYPE-1 ENDOLEAK. THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA AORTIC EXTENDER ENDOPROSTHESES. THE ENDOLEAK WAS RESOLVED. THE PT TOLERATED THE PROCEDURE WELL.

    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 8589475

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R ASPIRIN| METOPROLOL| PLAVIX| LISINOPROL| VYTORIN