BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22183472 · Received June 11, 2025

    Report

    Report Number
    2124215-2025-38146
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 11, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARTERIAL SHEATH CAUSED A DISSECTION, REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. ACCESS OF THE LEFT COMMON CAROTID ARTERY (CCA) WAS OBTAINED. IN THE PROCESS OF INSERTING THE ARTERIAL SHEATH OF THE NPS, A DISSECTION OCCURRED. THE NPS WAS SET UP FOLLOWING SHEATH INSERTION. AFTER ASSESSING THE SEVERITY OF THE DISSECTION VIA AN ANGIOGRAM, THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). THE CEA WAS COMPLETED, AND THE PATIENT CONDITION WAS REPORTED AS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85471 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306523 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention