BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 8332419 · Received February 12, 2019

    Report

    Report Number
    3007215228-2019-00001
    Event Type
    Injury
    Date Received
    February 12, 2019
    Date of Event
    January 2, 2019
    Report Date
    January 2, 2019
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED TCAR STEPS (CUTDOWN, VENOUS ACCESS, ARTERIAL SHEATH ACCESS, AND NPS SYSTEM ESTABLISHING PASSIVE REVERSE FLOW) PER IFU RECOMMENDATIONS. AFTER TCAR TIME OUT, RUMMEL CLAMP ESTABLISHED PASSIVE REVERSE FLOW. REVERSE FLOW CONFIRMED AT VENOUS SHEATH. BLEEDING FROM THE ARTERY WAS NOTED DURING 014 WIRE CROSSING/BALLOONING. PHYSICIAN STATED HE WAS ALMOST DONE AND APPLIED INTERMITTENT FINGER PRESSURE ON THE ARTERY TO STOP THE BLEEDING AND CONTINUED WITH STENT DEPLOYMENT, 2 MIN REVERSE FLOW, AND 2 VIEWS OF STENT COMPLETED. 014 WIRE REMOVED. AFTER RUMMEL WAS RELAXED AND PASSIVE FLOW ESTABLISHED, NPS WAS DISCONNECTED FROM ARTERIAL SHEATH, RETURNING BLOOD TO VENOUS SHEATH. ARTERIAL SHEATH WAS REMOVED, CLOSED WITH 5.0 PRE-STICH, SMALL TEAR IN ARTERY VISUALIZED WHERE SHEATH WAS INTRODUCED. PHYSICIAN PLACED RUMMEL AND CLAMP ON ARTERY TO CONTROL BLEEDING. 1 OR 2 5.0 PROLENES (SUTURES) WERE USED TO CLOSE TEAR IN ARTERY. RUMMEL AND CLAMP REMOVED. ULTRASOUND WAS USED TO ENSURE VELOCITY AND VISUAL THE ARTERY. ADDITIONAL 5.0 PROLENE USED TO CLOSE ARTERY. ARTERIOTOMY BLEEDING HAD STOPPED AND REMAINED DRY. ROUTINE SURGICAL CLOSE WAS PERFORMED. PATIENT WOKE FROM GENERAL NEUROLOGICALLY INTACT. PATIENT BROUGHT TO RECOVERY. NO FURTHER INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126678 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM ENROUTE NPS NTE SILK ROAD MEDICAL SR-200-NPS 201407 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention