BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH

    MDR report key: 974278 · Received January 3, 2008

    Report

    Report Number
    2017233-2007-00445
    Event Type
    Injury
    Date Received
    January 3, 2008
    Date of Event
    December 10, 2007
    Report Date
    January 3, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULTS - A REVIEW OF THE MANUFACTURING PAPERWORK COULD NOT BE CONDUCTED. THIS EVENT ALSO INVOLVES GORE EXCLUDER AAA ENDOPROSTHESES. PLEASE REFERENCE MEDWATCH 2953161-2007-00212.

    Description of Event or Problem · 1

    AS REPORTED, IN 2007, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES FOR THE TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. AN 18FR GORE INTRODUCER SHEATH WAS USED IN IMPLANTING THE EXCLUDER. THE RIGHT EXTERNAL ARTERY DISSECTED UPON REMOVAL OF THE SHEATH. THE DAMAGE WAS SURGICALLY REPAIRED. THE PT IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH GORE INTRODUCER SHEATH DYB W.L. GORE & ASSOCIATES,INC WLG345 10119

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention