BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE INTRODUCER SHEATH

    MDR report key: 1674420 · Received April 29, 2010

    Report

    Report Number
    2017233-2010-00198
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 28, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K013282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. THE TRUNK AND CONTRALATERAL LEG WERE PLACED WITHOUT INCIDENT, BUT DURING WITHDRAWAL OF THE 20 FR GORE INTRODUCER SHEATH, THE COMMON AND EXTERNAL ILIAC ARTERIES RUPTURED LONGITUDINALLY. ANOTHER CONTRALATERAL LEG WAS PLACED IN AN ATTEMPT TO COVER THE RUPTURE, BUT THE PT EXPIRED DUE TO SUBSTANTIAL BLOOD LOSS. ACCORDING TO THE PHYSICIAN, THE PT EXPERIENCED SUBSTANTIAL BLOOD LOSS BEFORE THE SECOND CONTRALATERAL LEG WAS PLACED, AND THE ARTERY MAY HAVE ALREADY RUPTURED WHEN THE SHEATH WAS RETRACTED EARLIER IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH DYB / INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES WLG345 2822808

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death