BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE NEUROPROTECTION SYSTEM

    MDR report key: 12076193 · Received June 28, 2021

    Report

    Report Number
    3014526664-2021-00092
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 28, 2021
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LED TO THE ADVERSE EVENT REPORTED. COMPLAINTS WILL CONTINUE TO BE REVIEWED AND MONITORED FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE COMPLETION OF A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED APHASIA APPROXIMATELY 6 HOURS POST-PROCEDURE. AN MRI SHOWED MICRO-EMBOLI ON THE IPSILATERAL SIDE. THE PATIENT'S SYMPTOMS WERE IMPROVING AS THE PATIENT WAS USING VERY COHERENT SHORT PHRASES. NO P2Y12 INHIBITOR TESTING HAS BEEN PERFORMED ON THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973805 ENROUTE NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL INC. SR-200-NPS 301457 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability