BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2211376 · Received August 8, 2011

    Report

    Report Number
    2953161-2011-00176
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 8, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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), 2010, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNK DATE, A CT SCAN REVEALED ANEURYSM ENLARGEMENT. ON (B)(6), 2011, THE PT UNDERWENT AN ADD'L PROCEDURE. THE PHYSICIAN BALLOONED THE CONTRALATERAL SIDE, SHOT CONTRAST, AND NO ENDOLEAKS WERE REVEALED. HE THEN IMPLANTED A CONTRALATERAL LEG COMPONENT ON THE IPSILATERAL SIDE TO ADDRESS WHAT WAS THOUGHT TO BE A DISTAL TYPE I ENDOLEAK. UPON FLUSHING MORE CONTRAST, A TYPE II ENDOLEAK WAS REVEALED. THE PHYSICIAN LEFT THE TYPE II ENDOLEAK AND 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 7671233

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R