BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OGRE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3641993 · Received February 5, 2014

    Report

    Report Number
    2017233-2014-00047
    Event Type
    Injury
    Date Received
    February 5, 2014
    Date of Event
    March 27, 2013
    Report Date
    January 10, 2014
    Manufacturer
    W.L. GORE AND ASSOCAITES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE STATES: TYPE II ENDOLEAKS ARE DEFINED AS RETROGRADE FLOW THROUGH PATENT COLLATERAL VESSELS INTO THE PERIGRAFT SPACES (I.E., ANEURYSMAL SAC), WHICH HAVE BEEN EXCLUDED BY THORACIC OR ABDOMINAL ENDOGRAFT PLACEMENT. A TYPE II ENDOLEAK CAN ORIGINATE FROM ANY OF THE AORTIC BRANCH VESSELS, INCLUDING BUT NOT LIMITED TO; INTERCOSTAL, LEFT SUBCLAVIAN, PHARYNGEAL, LUMBAR, INFERIOR MESENTERIC, HYPOGASTRIC, SACRAL, GONADAL, OR ACCESSORY RENAL ARTERIES USER ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 60MM IN DIAMETER, AND WAS IMPLANTED WITH GORE EXCLUDER ENDOPROSTHESES, FEATURING THE C3 DELIVERY SYSTEM. THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2013, THE PT UNDERWENT RE-INTERVENTION FOR A TYPE II ENDOLEAK. EMBOLIZATION WAS ATTEMPTED BUT WAS UNABLE TO BE PERFORMED DUE TO POOR ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75118 OGRE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE AND ASSOCAITES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| O| R