BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 9373400 · Received November 25, 2019

    Report

    Report Number
    3014526664-2019-00081
    Event Type
    Death
    Date Received
    November 25, 2019
    Date of Event
    October 29, 2019
    Report Date
    November 25, 2019
    Manufacturer
    SILK ROAD MEDICAL, INC.
    Product Code
    NIM
    UDI-DI
    00811311020539
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS, THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR ANY TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC (B)(6) MALE PATIENT UNDERWENT A RIGHT TRANSCAROTID REVASCULARIZATION PROCEDURE ON (B)(6) 2019. IT WAS NOTED THAT THERE WAS SIGNIFICANT CALCIUM IN THE INTERNAL CAROTID ARTERY (ICA). CAROTID ENDARTERECTOMY (CEA) AND TRANSFEMORAL CAROTID ARTERY STENTING (TF-CAS) WERE NOT AN OPTION FOR THIS PATIENT. THE PHYSICIAN CROSSED THE LESION AND PRE DILATED WITH A 5X30 BALLOON. A STENT WAS PLACED. THE PATIENT WOKE UP NEURO INTACT, BUT PRESENTED WITH A STROKE THROUGHOUT THE NIGHT. A FOLLOW UP CT WAS PERFORMED WHICH SHOWED THAT THE STENT WAS CRIMPED AND THROMBOSED. AN EMBOLECTOMY WAS PERFORMED. PATIENT EXPIRED THREE DAYS POST TCAR PROCEDURE. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164473 ENROUTE TRANSCAROTID STENT SYSTEM ENROUTE SDS NIM SILK ROAD MEDICAL, INC. SR-1040-CS 17858027 00811311020539

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R