BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 11662636 · Received April 14, 2021

    Report

    Report Number
    3014526664-2021-00043
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 13, 2021
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NIM
    UDI-DI
    00811311020508
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ALTHOUGH 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. A SECONDARY MDR WAS REPORTED UNDER 3014526664-2021-00045 (B)(4) AS IT IS UNKNOWN WHICH STENT MAY HAVE CAUSED THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 13 DAYS AFTER THE COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WAS RE-ADMITTED TO THE EMERGENCY DEPARTMENT DUE TO NECK HEMATOMA AND ARM WEAKNESS. AN ANGIOGRAM WAS PERFORMED AND SHOWED PARTIAL STENT THROMBOSIS. THE PATIENT WAS REFERRED TO A LOCAL VASCULAR SURGEON FOR ADDITIONAL PATIENT CARE. AT THIS TIME, IT IS UNKNOWN WHETHER THE PATIENT WAS PLAVIX RESISTANT. THE PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563950 ENROUTE TRANSCAROTID STENT SYSTEM TSS NIM SILK ROAD MEDICAL INC. SR-0940-CS 17858026 00811311020508

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability