BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID STENT

    MDR report key: 25311227 · Received May 27, 2026

    Report

    Report Number
    2124215-2026-28564
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 27, 2026
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NIM
    UDI-DI
    00811311020508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM HAD UNRAVELED AND A BLACK FRAGMENT WAS FOUND IN THE NEUROPROTECTION SYSTEM(NPS) FILTER FOLLOWING THE PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED WITH NO ISSUES REPORTED. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE SPRING HAD UNRAVELED AT THE DISTAL TIP. POST PROCEDURE, A BLACK FRAGMENT WAS FOUND IN THE NPS FILTER. UPON FURTHER INSPECTION OF THE STENT DELIVERY SYSTEM, THE BLACK FRAGMENT FOUND IN THE FILTER APPEARS TO HAVE BROKEN OFF THE DELIVERY SYSTEM. NO INTERVENTION WAS REQUIRED AS RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14512 ENROUTE TRANSCAROTID STENT STENT, CAROTID NIM SILK ROAD MEDICAL SR-0940-CS 0018310189 00811311020508

    Patients

    Seq Age Sex Outcome Treatment
    1