BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL SHEATH

    MDR report key: 3864581 · Received June 10, 2014

    Report

    Report Number
    2017233-2014-00303
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 8, 2014
    Report Date
    August 6, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 EVALUATION 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 PATIENT, INCLUDING DEATH, MAY RESULT. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS BEING TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESIS, AND ILIAC BRANCH ENDOPROSTHESIS. A DRYSEAL SHEATH WITH HYDROPHILIC COATING WAS USED DURING THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2014, AN ARTERIOTOMY (FOCAL ENDARTERECTOMY AND PATCH) WAS PERFORMED. THE LEFT FEMORAL ARTERY REQUIRED CONVERSION FROM PERCUTANEOUS TO OPEN FEMORAL REPAIR DUE TO THE LEFT FEMORAL ARTERY FALLING APART (1000-E:-OTHER EXPLAINED IN FILE), FRIABLE, AND DISSECTED IN THE POSTERIOR WALL DUE TO THE DRYSEAL SHEATH BEING INSERTED. BLOOD LOSS WAS AVERAGE (APPROXIMATELY 400ML), NO BLOOD TRANSFUSION WAS NEEDED. THE PATIENT TOLERATED THE PROCEDURE WITH NO FURTHER SEQUELA.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS BEING TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND ILIAC BRANCH ENDOPROSTHESIS. IT WAS REPORTED THAT ON (B)(6) 2014, AN ARTERIOTOMY (FOCAL ENDARTERECTOMY AND PATCH) WAS PERFORMED. THE LEFT FEMORAL ARTERY REQUIRED CONVERSION FROM PERCUTANEOUS TO OPEN FEMORAL REPAIR DUE TO THE LEFT FEMORAL ARTERY FALLING APART, FRIABLE, AND DISSECTED IN THE POSTERIOR WALL. BLOOD LOSS WAS AVERAGE (APPROXIMATELY 400 ML), NO BLOOD TRANSFUSION WAS NEEDED. THE PATIENT TOLERATED THE PROCEDURE WITH NO FURTHER SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339079 GORE® DRYSEAL SHEATH INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES 12272087

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention