BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 7044245 · Received November 19, 2017

    Report

    Report Number
    3007215228-2017-00011
    Event Type
    Injury
    Date Received
    November 19, 2017
    Date of Event
    October 19, 2017
    Report Date
    November 19, 2017
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING ENROUTE NPS ARTERIAL SHEATH EXCHANGE OVER .035 WIRE USING STOP SHORT TECHNIQUE, IT WAS NOTICED ON FLUOROSCOPY THE TAPERED FLOPPY PORTION OF THE .035 WIRE WAS MORE PROXIMAL ON SHEATH ENTRY AND CREATED A DISSECTION IN THE CCA. THE SUTURES WERE REMOVED AND ENROUTE NPS ARTERIAL SHEATH WAS RETRACTED TO BACK OUT OF THE DISSECTION PLANE. THE ENOUTE NPS WAS CONNECTED PER ROUTINE. THE .014 WIRE WAS DIRECTED INTO THE ICA AND CONTINUE THE PROCEDURE. A SECOND STENT WAS PLACED PROXIMAL AND OVERLAPPING ONTO THE CCA TO COVER AND REPAIR THE DISSECTION PLANE SUCCESSFULLY. THE PHYSICIAN RETRACTED THE ENROUTE NPS ARTERIAL SHEATH SLIGHTLY TO ALLOW FOR APPROPRIATE STENTING LENGTH FOR DEPLOYMENT WITH EASE AND SUCCESS. THE PATIENT REMAINED STABLE WITH NO CHANGES FROM BASELINE EEG THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823447 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM ENROUTE NPS NTE SILK ROAD MEDICAL SR-200-NPS 200887

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention