BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH

    MDR report key: 463269 · Received May 30, 2003

    Report

    Report Number
    2953161-2003-00005
    Event Type
    Injury
    Date Received
    May 30, 2003
    Date of Event
    April 29, 2003
    Report Date
    May 29, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOTH COMPONENTS OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE) WERE DEPLOYED WITHOUT INCIDENT. THE SURGEON COMMENTED THAT THE 18 FRENCH GORE INTRODUCER SHEATH WAS SNUG; HOWEVER, THERE WERE NO PROBLEMS ADVANCING IT TO THE SITE. COMPLETION ANGIO SHOWED NO PROBLEMS. UPON REMOVAL OF THE 18 FR SHEATH THE ILIAC ARTERY FELL APART APRROX 2CM DISTAL TO THE EBE IN THE LEFT GROIN. AN AORTIC BALLOON WAS PLACED TO CONTROL THE BLEEDING. THE SURGEON ATTEMPTED PLACEMENT OF TWO GRAFT EXTENSIONS (ANEURX), WHICH FAILED. THEY THEN IMPLANTED AN 8-MM HEMASHIELD GRAFT WITH 2 CM OF GOOD ARTERY DISTAL TO THE EBE; BOTH ANASTOMOSES WERE FASHIONED WITH RUNNING PROLINE SUTURE AND GOOD PERFUSION TO THE LEFT LEG WAS ESTABLISHED. GORE REP OBSERVED THAT THE ARTERY WAS IN POOR SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH SHEATH MIH W.L. GORE & ASSOCIATES,INC WLG325 131565

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention