BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1893435 · Received November 5, 2010

    Report

    Report Number
    2017233-2010-00493
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 4, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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. ADDITIONAL GORE EXCLUDER DEVICES RELATED TO THIS EVENT: PXC181000/(B)(4), PXC141400/(B)(4), AND PXC201000/(B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6), 2010, COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED A POSSIBLE TYPE-2 ENDOLEAK WITH ANEURYSM ENLARGEMENT, HOWEVER, THE AMOUNT OF GROWTH WAS INDETERMINATE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PT.

    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 7362116

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other ASPIRIN