BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 14593450 · Received June 3, 2022

    Report

    Report Number
    3014526664-2022-00076
    Event Type
    Death
    Date Received
    June 3, 2022
    Date of Event
    April 17, 2022
    Report Date
    June 3, 2022
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NIM
    UDI-DI
    00811311020508
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SECONDARY MDR WAS REPORTED UNDER 3014526664-2022-00077 AS THERE ARE TWO STENTS ASSOCIATED WITH THE SAME EVENT/PATIENT. THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A REVIEW OF THE 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, THEREFORE, THE COMPLAINT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION. COMPLAINTS WILL CONTINUE TO BE REVIEWED AND MONITORED FOR TRENDS. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO DAYS AFTER COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT'S STENT THROMBOSED. A STROKE OCCURRED, AND THE PATIENT WAS PARALYZED ON THE RIGHT LEG AND ARM. THE PHYSICIAN PERFORMED A THROMBECTOMY AND BALLOON ANGIOPLASTY AND PLACED THE PATIENT ON TICAGRELOR/BRILINTA. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 INDICATED THAT PATIENT WAS IN THE HOSPITAL FOR 30 DAYS AND THEN WAS DISCHARGED. THE PATIENT WENT TO A REHABILITATION FACILITY AND SUBSEQUENTLY PASSED AWAY. THE CAUSE AND DATE OF DEATH ARE UNKNOWN. AT THIS TIME, THERE IS NO INDICATIONS AS TO WHAT MAY HAVE CAUSED THE THROMBUS, OR IF THE REPORTED FAILURE IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO DUAL ANTIPLATELET THERAPY (DAPT) MEDICATION, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586408 ENROUTE TRANSCAROTID STENT SYSTEM ENROUTE TSS NIM SILK ROAD MEDICAL INC. SR-094-CS 18034547 00811311020508

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death| S| R