BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 24323233 · Received February 12, 2026

    Report

    Report Number
    2124215-2026-07962
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 27, 2026
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 A DISSECTION OCCURRED AS A RESULT OF ARTERIAL SHEATH INSERTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS AT THE ACCESS SITE AND DURING INSERTION OF THE ARTERIAL SHEATH OF THE NPS, A DISSECTION OCCURRED. THE PHYSICIAN ELECTED TO ABORT THE TCAR PROCEDURE AND PLACED A SURGICAL PATCH TO FIX THE DISSECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED AS A RESULT OF ARTERIAL SHEATH INSERTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS AT THE ACCESS SITE AND DURING INSERTION OF THE ARTERIAL SHEATH OF THE NPS, A DISSECTION OCCURRED. THE PHYSICIAN ELECTED TO ABORT THE TCAR PROCEDURE AND PLACED A SURGICAL PATCH TO FIX THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387034 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306921 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Required Intervention