BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE NEUROPROTECTION SYSTEM

    MDR report key: 11697523 · Received April 20, 2021

    Report

    Report Number
    3014526664-2021-00050
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 21, 2021
    Report Date
    April 20, 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
    ME, 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 AFTER A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED RIGHT SIDED STROKE. THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590105 ENROUTE NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL INC SR-200-NPS 301487 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability