BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 473311 · Received July 22, 2003

    Report

    Report Number
    2953161-2003-00019
    Event Type
    Injury
    Date Received
    July 22, 2003
    Date of Event
    March 12, 2003
    Report Date
    July 22, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING CANNULATION OF THE CONTRALATERAL LEG HOLE OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE), SHEATH ACCESS ON THE RIGHT SIDE WAS LOST, RESULTING IN APPROXIMATELY 950ML OF BLOOD LOSS. TWO UNITS OF BLOOD WERE GIVEN. WHEN THE PT WAS DEEMED STABLE, THE DEPLOYMENT OF THE CONTRALATERAL LEG WAS COMPLETED WITH AN EXCELLENT RESULT. THIS EVENT WAS NOT RELATED TO THE EBE, BUT RATHER A PROCEDURAL ISSUE WITH A VASCULAR ACCESS DEVICE ONLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention