BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 6001956 · Received October 5, 2016

    Report

    Report Number
    3007215228-2016-00003
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    September 16, 2016
    Report Date
    October 5, 2016
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311020744
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    AFTER INTRODUCTION OF THE ENROUTE NEUROPROTECTION SYSTEM (NPS), IT WAS NOTED THE FLUSHING ARM WOULD NOT ASPIRATE WITH EASE AND HAD SOME AIR. IT WAS MENTIONED AS IT SEEMED AS IF IT WAS ON THE BACK WALL. PHYSICIAN RETRACTED THE SHEATH A SHORT DISTANCE AND THE SHEATH ASPIRATED WITH EASE AND WAS ABLE TO FLUSH. ON SUBSEQUENT ANGIOGRAM, DISSECTION WITH EXTRAVASATION NOTED IN THE LCCA. SHEATH WAS REMOVED AND VESSEL CLAMPED WHILE SOME CARE WAS GIVEN TO ARTERIOTOMY BY PHYSICIAN THEN THE SHEATH REPLACED. SHEATH WAS ASPIRATED AND FLUSHED AND ANGIOGRAM SHOWED BETTER LUMEN FILLING WITH DISSECTION AND EXTRAVASATION. PHYSICIAN FELT WE COULD STENT OVER THE FLAP AND PROCEDURE CONTINUED. NPS CONNECTED AND FLOW REVERSAL INITIATION PER ROUTINE. WIRE PLACED ACROSS LESION. PRE DILATION, STENT AND POST DILATATION PERFORMED. LUMEN VISUALIZATION VASTLY IMPROVED BUT STILL SOME STAINING. SECOND STENT PLACED OVER LAPPING STENT UP TO THE EDGE OF THE NPS SHEATH. ANGIOGRAM PERFORMED. PROCEDURE COMPLETED. DRAIN PLACED AND PROTAMINE GIVEN. PATIENT EXTUBATED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652833 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM ENROUTE NPS NTE SILK ROAD MEDICAL SR-200-NPS 200576 00811311020744

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention