BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 9348601 · Received November 20, 2019

    Report

    Report Number
    3014526664-2019-00080
    Event Type
    Death
    Date Received
    November 20, 2019
    Date of Event
    October 2, 2019
    Report Date
    November 20, 2019
    Manufacturer
    SILK ROAD MEDICAL, INC.
    Product Code
    NIM
    UDI-DI
    00811311020478
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN 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 LEAD TO THE ADVERSE EVENT REPORTED. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR ANY TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A LEFT TRANSCAROTID ARTERY REVASCULARIZATION PROCEDURE ON (B)(6) 2019. THE PATIENT CONFIRMED THAT HE HAD TAKEN HIS DAPT AND STATIN MEDICATION PRIOR TO THE PROCEDURE THAT MORNING. THE PROCEDURE WAS SUCCESSFUL AND IMMEDIATELY POST PROCEDURE THE PATIENT WOKE UP AT BASELINE. HOWEVER, TWO HOURS POST PROCEDURE THE PATIENT DEVELOPED STROKE LIKE SYMPTOMS. THE PATIENT WAS TAKEN TO NEURO INTERVENTION AND WAS FOUND TO HAVE A MECHANICALLY OPEN STENT FULL OF THROMBUS. A THROMBECTOMY WAS PERFORMED, HOWEVER, THE PATIENT DID NOT SURVIVE AFTER SEVERAL DAYS IN THE ICU. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140507 ENROUTE TRANSCAROTID STENT SYSTEM ENROUTE SDS NIM SILK ROAD MEDICAL, INC. SR-0840-CS 300731 00811311020478

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| R