BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1903503 · Received November 16, 2010

    Report

    Report Number
    2953161-2010-00206
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    June 4, 2010
    Report Date
    November 16, 2010
    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
    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 SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PT WAS IMPLANTED WITH SIX GORE EXCLUDER AAA ENDOPROSTHESES TO REPAIR A 7 CM ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2010, THE PT UNDERWENT A F/U COMPUTED TOMOGRAPHY THAT REVEALED THE ANEURYSM SAC AT 8.6 CM. NO ENDOLEAKS WERE NOTED. ON (B)(6) 2010, THE PT UNDERWENT A REINTERVENTION. THE PHYSICIAN STATED THERE MAY NOT HAVE BEEN PROPER PROXIMAL NECK FIXATION; HOWEVER, NO ENDOLEAKS WERE NOTED. THE PT WAS IMPLANTED WITH TWO AORTIC EXTENDER COMPONENTS. 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 WLG325 04165104

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R ASPIRIN| NIASPAN| LISINOPRIL| XALATAN| FAMOTIDINE