BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 3232267 · Received July 9, 2013

    Report

    Report Number
    3007284313-2013-00056
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    W. L. GORE ASSOCIATES INC.
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. CONCLUSION - ACCORDING TO THE GORE DRYSEAL SHEATH WITH HYDROPHILIC COATING INSTRUCTIONS FOR USE (IFU) STATES ADEQUATE VESSEL ACCESS IS REQUIRED TO INTRODUCE THE SHEATH INTO THE VASCULATURE. CAREFUL EVAL OF VESSEL SIZE, ANATOMY, TORTUOSITY, AND DISEASE STATE (INCLUDING CALCIFICATION, PLAQUE, AND THROMBUS) IS REQUIRED TO ENSURE SUCCESSFUL SHEATH INTRODUCTION AND SUBSEQUENT WITHDRAWAL. IF VESSEL IS NOT ADEQUATE FOR ACCESS, MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PT, INCLUDING DEATH, MAY RESULT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PT HAD SLIGHT TORTUOSITY AND HEAVY CALCIFICATION IN THE ILIAC ARTERIES. LEFT EXTERNAL ILIAC ARTERY MEASUREMENTS AT THE SMALLEST AREA WAS APPROX 6.4 TO 6.5MM. AT THE BEGINNING OF THE PROCEDURE, THE PHYSICIAN WAS INSERTING THE GORE DRYSEAL SHEATH (DSL 1828/11159476) INTO THE LEFT EXTERNAL ILIAC ARTERY. THE PHYSICIAN FELT SOME RESISTANCE UPON ADVANCING THE SHEATH BUT CONTINUED. IT WAS DISCOVERED THAT THE ILIAC ARTERY RUPTURED. BLOOD LOSS WAS MINIMAL. TWO GORE VIABAHN ENDOPROSTHESES WERE USED TO REPAIR THE ILIAC ARTERY. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313596 GORE DRYSEAL SHEATH DYB/INTRODUCER, CATHETER DYB W. L. GORE ASSOCIATES INC. 11159476

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention