BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1914909 · Received November 29, 2010

    Report

    Report Number
    2953161-2010-00218
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 24, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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. 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. ADD'L GORE DEVICES RELATED TO THE EVENT: PXC141200/(B)(4) AND PXL161207/(B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2007, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND A LEFT COMMON ILIAC ARTERY ANEURYSM. THE LEFT HYPOGASTRIC ARTERY WAS COIL OCCLUDED DURING THE PROCEDURE. ON (B)(6), 2010, A FOLLOW-UP ANGIOGRAM OF THE ABDOMEN AND BOTH COMMON ILIAC ARTERIES WAS PERFORMED. THE IMAGES REVEALED A TYPE-2 ENDOLEAK FROM THE INFERIOR MESENTERIC ARTERY AND INDETERMINATE ANEURYSM GROWTH. AN INTERVENTION IS NOT BEING PLANNED AT THIS TIME; HOWEVER, 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 04789379

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O CONCOMITANT MEDICATIONS INCLUDED, PLAVIX| ASPIRIN| GENERIC HYPERTENSIVE MEDICATIONS.