BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSCAROTID STENT SYSTEM

    MDR report key: 12149584 · Received July 9, 2021

    Report

    Report Number
    MW5102444
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    July 7, 2021
    Report Date
    July 8, 2021
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TRANSCAROTID STENT SYSTEM CATHETER WOULD NOT FULLY DEPLOY. COMPANY REPRESENTATIVE, SCOTT ZIMMERMAN, PRESENT AT THE TIME OF THE INCIDENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044739 TRANSCAROTID STENT SYSTEM STENT, CAROTID NIM SILK ROAD MEDICAL INC. SR-1040-CS 301616

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR