BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 8685320 · Received June 10, 2019

    Report

    Report Number
    3014526664-2019-00039
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 13, 2019
    Report Date
    June 10, 2019
    Manufacturer
    SILK ROAD MEDICAL, INC.
    Product Code
    NIM
    UDI-DI
    00811311020478
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IMPLANTED IN THE PATIENT AND THEREFORE, IT WAS NOT AVAILABLE FOR EVALUATION. 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. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR ANY TRENDS.

    Description of Event or Problem · 1

    A TCAR PROCEDURE WAS PERFORMED. PATIENT WAS ON ASPIRIN, PLAVIX AND STATIN. AFTER BALLOONING THE LEFT INTERNAL CAROTID ARTERY TO THE COMMON CAROTID ARTERY WITH ONE INFLATION, THE BALLOON WAS TAKEN OUT AND A STENT WAS PLACED INTO THE TARGET AREA. THE PATIENT STARTED TO NOT RESPOND TO QUESTIONS AND IT WAS DECIDED TO QUICKLY COMPLETE THE PROCEDURE. REVERSE FLOW WENT FOR 3 MINUTES AFTER THE STENT DEPLOYMENT. AFTER ONE VIEW OF THE STENT, THE STENT LOOKED PATENT SO THE PHYSICIAN TOOK THE ENROUTE NPS OFF AND COMPLETED THE TCAR PROCEDURE. THE PATIENT REGAINED HER ABILITY TO RESPOND TO QUESTIONS AS WELL AS THE MOVEMENTS IN HER HANDS AND FEET. TWO VIEWS OF THE BRAIN WERE TAKEN AND THE BRAIN WAS PATENT. LATER THAT DAY, PATIENT'S STENT OCCLUDED AND THE PATIENT HAD A STROKE. THE PATIENT ENDED UP GOING TO THE INTERVENTIONAL NEUROLOGY WHERE THE STENT WAS SUCTIONED AND THE THROMBUS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477891 ENROUTE TRANSCAROTID STENT SYSTEM ENROUTE SDS NIM SILK ROAD MEDICAL, INC. SR-0840-CS 201382 00811311020478

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention