BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22243521 · Received June 17, 2025

    Report

    Report Number
    2124215-2025-38226
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 16, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H6 - EVALUATION METHOD CODES; EVALUATION CONCLUSION CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS IDENTIFIED POST INSERTION OF THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS), REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN THE RIGHT SIDED TCAR PROCEDURE. SLUGGISH FLOW THROUGH THE NPS WAS IDENTIFIED AFTER INSERTION OF THE ARTERIAL SHEATH. A DISSECTION WAS DISCOVERED WHILE THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH 0.014" GUIDEWIRE. THE DISSECTION WAS REPAIRED WITH A PATCH AND THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS IDENTIFIED POST INSERTION OF THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS), REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN THE RIGHT SIDED TCAR PROCEDURE. SLUGGISH FLOW THROUGH THE NPS WAS IDENTIFIED AFTER INSERTION OF THE ARTERIAL SHEATH. A DISSECTION WAS DISCOVERED WHILE THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH 0.014" GUIDEWIRE. THE DISSECTION WAS REPAIRED WITH A PATCH AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630108 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306431 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention