BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 473283 · Received July 22, 2003

    Report

    Report Number
    2953161-2003-00018
    Event Type
    Injury
    Date Received
    July 22, 2003
    Date of Event
    February 20, 2003
    Report Date
    July 22, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE ORIENTING THE TRUNK-IPSILATERAL LEG COMPONENT OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE), THE INTRODUCER SHEATH USED CAME OUT OF THE PT. THE PT BECAME UNSTABLE DUE TO AN ESTIMATED BLOOD LOSS OF 1400CC. PT WAS GIVEN BLOOD AND VOLUME BUT REMAINED UNSTABLE ON AND OFF DURING THE PROCEDURE. PLACEMENT OF THE EBE WAS SUCCESSFULLY COMPLETED. FOLLOW UP WITH THE PHYSICIAN THE FOLLOWING DAY REVEALED THAT THE PT WAS DOING FINE. 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 79 YR Required Intervention