BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE NEUROPROTECTION SYSTEM

    MDR report key: 11960159 · Received June 8, 2021

    Report

    Report Number
    3014526664-2021-00086
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    April 28, 2021
    Report Date
    June 8, 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
    OH, 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 MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LED TO THE ADVERSE EVENT REPORTED. THERE IS NO INDICATION THAT A MALFUNCTION OF THE SRM DEVICE OCCURRED. THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. SILK ROAD MEDICAL WILL CONTINUE TO MONITOR FOR OCCURRENCES OF SIMILAR EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED SUBSEQUENT TO A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED A STROKE. THE PATIENT'S CONDITION WAS STABLE. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION, AS IT IS UNCLEAR IF THE ADVERSE EVENT WAS CAUSED BY THE PROCEDURE, PATIENT RESPONSE OR THE MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856043 ENROUTE NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL INC SR-200-NPS 301385 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability