BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 23645801 · Received November 25, 2025

    Report

    Report Number
    2124215-2025-85610
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 25, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION WAS IDENTIFIED REQUIRING AN ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE ARTERIAL SHEATH AND 0.035 J-TIP WIRE OF THE NPS DEVICE CAUSED A DISSECTION DURING INSERTION REQUIRING AN ADDITIONAL STENT TO FULLY COVER THE DISSECTION. THE PATIENT EMERGED FROM THE PROCEDURE NEUROLOGICALLY INTACT AND WAS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830098 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306508 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention