BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE NEUROPROTECTION SYSTEM

    MDR report key: 8505850 · Received April 11, 2019

    Report

    Report Number
    3014526664-2019-00023
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 11, 2019
    Manufacturer
    SILK ROAD MEDICAL, INC
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 PRODUCT MALFUNCTION REPORTED. ADDITIONALLY, THIS IS THE FIRST REPORTED PRODUCT MALFUNCTION OF THIS NATURE ASSOCIATED WITH THIS LOT. A ROOT CAUSE COULD NOT BE CONCLUSIVELY IDENTIFIED AT THIS TIME. THEREFORE, OUT OF AN ABUNDANCE OF CAUTION, THIS REPORT IS BEING SUBMITTED.

    Description of Event or Problem · 1

    AFTER THE INITIAL 10X40 ENROUTE STENT WAS PLACED, THE SURGEON OBSERVED A THROMBOEMBOLISM IN THE DISTAL LEFT ICA JUST ABOVE THE DISTAL END OF THE STENT. SHE DECIDED TO PLACE A SECOND 8X30 ENROUTE STENT WHERE THE THROMBOEMBOLISM WAS LOCATED TO COVER IT. ONCE THIS WAS DONE, THE THROMBOEMBOLISM APPEARED TO BE CONTAINED. CASE WAS THEN COMPLETED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299277 ENROUTE NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL, INC SR-200-NPS 300135 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention