BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 8591776 · Received May 8, 2019

    Report

    Report Number
    3007215228-2019-00028
    Event Type
    Death
    Date Received
    May 8, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 8, 2019
    Manufacturer
    SILK ROAD MEDICAL, INC.
    Product Code
    NIM
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LEAD TO THE ADVERSE EVENT REPORTED. ADDITIONALLY, THIS WAS THE FIRST REPORTED ADVERSE EVENT OF THIS NATURE ASSOCIATED WITH THIS LOT. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A NORMAL TCAR PROCEDURE WAS PERFORMED. THE PATIENT WAS HIGH RISK BASED OFF OF A LESION. AFTER THE PROCEDURE, THE STAFF TRIED TO WAKE THE PATIENT, BUT THE PATIENT WAS UNRESPONSIVE. AN ULTRASOUND WAS PERFORMED ON THE PATIENT AND IT WAS NOTED THAT THE STENT WAS OCCLUDED. A CEA PROCEDURE WAS PERFORMED TO REMOVE THE STENT. DURING THE PROCEDURE, A LARGE CLOT IN THE MIDDLE OF THE STENT WAS DISCOVERED. AFTER THE CEA PROCEDURE, THE PATIENT HAD A MASSIVE STROKE AND PASSED AWAY. IT WAS NOTED THAT THE PATIENT HAD AN INTRALUMINAL FILLING DEFECT, RESULTING IN PLAQUE PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384203 ENROUTE TRANSCAROTID STENT SYSTEM STENT SDS NIM SILK ROAD MEDICAL, INC. SR-1040-CS 201265

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death