BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 8708443 · Received June 18, 2019

    Report

    Report Number
    3014526664-2019-00041
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    May 31, 2019
    Report Date
    June 18, 2019
    Manufacturer
    SILK ROAD MEDICAL, INC.
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND COULD NOT BE EVALUATED. 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

    DURING A TCAR PROCEDURE, PATIENT EXPERIENCED A DISSECTION INVOLVING THE ENROUTE NPS DEVICE. THE DISSECTION WAS SURGICALLY REPAIR WITH A PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502475 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL, INC. SR-200-NPS 300311 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention