BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22872861 · Received August 22, 2025

    Report

    Report Number
    2124215-2025-58808
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 23, 2025
    Report Date
    December 18, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: E1 - INITIAL REPORTER EMAIL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED, REQUIRING AN ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MICRO NEEDLE, 0.014 GUIDEWIRE, AND SHEATH WERE INSERTED SUCCESSFULLY. TWO ANGIOGRAPHY IMAGES OF THE EXTERNAL CAROTID ARTERY (ECA) WERE TAKEN. THE MICRO WIRE AND MICRO SHEATH WERE ADVANCED FROM THE ICA INTO THE ECA, AND 0.014 WIRE WAS EXCHANGED FOR THE J-WIRE OF THE NPS. THE MICRO SHEATH WAS REMOVED, AND THE ARTERIAL SHEATH WAS INSERTED. TWO ANGIOGRAPHY VIEWS OF THE ARTERIAL SHEATH REVEALED A DISSECTION OF THE COMMON CAROTID ARTERY (CCA). THE SHEATH WAS PULLED BACK AND PROCEDURE COMPLETED AS PLANNED, WITH THE PLACEMENT OF AN ADDITIONAL STENT TO COVER THE DISSECTION. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED, REQUIRING AN ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MICRO NEEDLE, 0.014 GUIDEWIRE, AND SHEATH WERE INSERTED SUCCESSFULLY. TWO ANGIOGRAPHY IMAGES OF THE EXTERNAL CAROTID ARTERY (ECA) WERE TAKEN. THE MICRO WIRE AND MICRO SHEATH WERE ADVANCED FROM THE ICA INTO THE ECA, AND 0.014 WIRE WAS EXCHANGED FOR THE J-WIRE OF THE NPS. THE MICRO SHEATH WAS REMOVED, AND THE ARTERIAL SHEATH WAS INSERTED. TWO ANGIOGRAPHY VIEWS OF THE ARTERIAL SHEATH REVEALED A DISSECTION OF THE COMMON CAROTID ARTERY (CCA). THE SHEATH WAS PULLED BACK AND PROCEDURE COMPLETED AS PLANNED, WITH THE PLACEMENT OF AN ADDITIONAL STENT TO COVER THE DISSECTION. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503605 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306440 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention