BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22342606 · Received June 26, 2025

    Report

    Report Number
    2124215-2025-41509
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    May 29, 2025
    Report Date
    October 20, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: E1- INITIAL REPORTER EMAIL.

    Additional Manufacturer Narrative · 0

    H6: EVALUATION CONCLUSION CODE WAS UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED AS A RESULT OF THE ARTERIAL SHEATH REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING ACCESS THE ARTERIAL SHEATH OF THE NPS CAUSED A DISSECTION RESULTING IN THE INABILITY TO CROSS THE LESION. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED AS A RESULT OF THE ARTERIAL SHEATH REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING ACCESS THE ARTERIAL SHEATH OF THE NPS CAUSED A DISSECTION RESULTING IN THE INABILITY TO CROSS THE LESION. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED AS A RESULT OF THE ARTERIAL SHEATH REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING ACCESS THE ARTERIAL SHEATH OF THE NPS CAUSED A DISSECTION RESULTING IN THE INABILITY TO CROSS THE LESION. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940216 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306348 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention