BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1011899 · Received March 11, 2008

    Report

    Report Number
    2017233-2008-00086
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 10, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET LAL PRE-RELEASE SPECIFICATIONS. VESSEL DISSECTION. ALSO IMPLANTED IN THE PT (PXC121200/LOT#05613994 AND PXL161007/LOT#05622753).

    Description of Event or Problem · 1

    AS REPORTED IN 2008, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. THE PT'S ACCESS VESSELS WERE REPORTED TO BE VERY STENOSED, TORTUOUS AND CALCIFIED. THE LEFT COMMON FEMORAL ARTERY AND/OR THE LEFT EXTERNAL ILIAC ARTERY WERE DISSECTED WHEN THE 18FR COOK INTRODUCER SHEATH WAS AGGRESSIVELY INTRODUCED. POST-OPERATIVELY A PORTION OF THE TRUNK-IPSILATERAL LEG COMPONENT BEGAN TO THROMBOSE DISTAL FROM THE COMMON ILIAC INTO THE EXTERNAL ILIAC ARTERY. A REINTERVENTION WAS PERFORMED WITH AN ANGIOGRAPHY JET TO REMOVE THE THROMBUS. SOON THEREAFTER, THE PT'S LEFT COMMON EXTERNAL ILIACS BEGAN TO OCCLUDE WITH THROMBUS. A FEM-FEM BYPASS WAS PERFORMED. THE PT IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES, INC WLG325 05696579

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention