BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1903461 · Received November 15, 2010

    Report

    Report Number
    2017233-2010-00501
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 12, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED AND RELATED TO THIS EVENT; PXT261414/(B)(4), PXC161000/(B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2007, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A TYPE II ENDOLEAK FROM A PATENT INFERIOR MESENTERIC ARTERY WAS NOTED. ON APPROXIMATELY (B)(6), 2010, A ROUTINE COMPUTED TOMOGRAPHY REVEALED ANEURYSM GROWTH OF 9MM. IT WAS REPORTED THAT THE TYPE II ENDOLEAK HAD RESOLVED AND THE INFERIOR MESENTERIC ARTERY WAS OCCLUDED. NO TREATMENT OR REINTERVENTION HAS BEEN SCHEDULED. THE PHYSICIAN HAS DECIDED TO TAKE A WAIT AND WATCH APPROACH AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANERUYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG425 04588907

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other