BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 11767775 · Received May 4, 2021

    Report

    Report Number
    3014526664-2021-00060
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 3, 2021
    Manufacturer
    SILK ROAD MEDICAL INC
    Product Code
    NIM
    UDI-DI
    00811311020478
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 THE COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED STROKE SYMPTOMS. THE PATIENT PRESENTED WITH TREMOR OF THE RIGHT UPPER EXTREMITY AND RIGHT HEMIPARESIS ROUGHLY 24 HOURS POST PROCEDURE. THE PATIENT WAS EMERGENTLY TAKEN TO THE OPERATING ROOM FOR A LEFT CAROTID THROMBECTOMY, EXPLANTATION OF THE STENT, AND BYPASS SURGERY OF THE LEFT CAROTID ARTERY. THE PATIENT IS REPORTED AS STABLE AND REMAINS INTUBATED AND ON A VENTILATOR. 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
    664581 ENROUTE TRANSCAROTID STENT SYSTEM TSS NIM SILK ROAD MEDICAL INC SR-0840-CS 301693 00811311020478

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention| S