BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22613363 · Received July 25, 2025

    Report

    Report Number
    2124215-2025-48534
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 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 OCCURRED, REQUIRING ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. UPON INSERTION OF ARTERIAL SHEATH OVER THE 0.35 GUIDEWIRE, A DISSECTION WAS CONFIRMED ANGIOGRAPHICALLY. AN ADDITIONAL UNPLANNED STENT WAS PLACED TO TREAT THE DISSECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WOKE UP NEUROLOGICALLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286524 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306579 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention