BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 12046236 · Received June 22, 2021

    Report

    Report Number
    3014526664-2021-00090
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 29, 2021
    Report Date
    June 22, 2021
    Manufacturer
    SILK ROAD MEDICAL INC
    Product Code
    NIM
    UDI-DI
    00811311020447
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER THE COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED SEVERE STENT COMPRESSION. THE PHYSICIAN ELECTED TO REMOVE THE STENT TO RESOLVE THE REPORTED ISSUE. THE LESION WAS CALCIFIED AND NO P2Y12 INHIBITOR TEST WAS PERFORMED ON THIS PATIENT. THE PATIENT WAS NEUROLOGICALLY INTACT AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938339 ENROUTE TRANSCAROTID STENT SYSTEM TSS NIM SILK ROAD MEDICAL INC SR-0740-CS 17991342 00811311020447

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention| S