BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 24619281 · Received March 17, 2026

    Report

    Report Number
    2124215-2026-14667
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 17, 2026
    Report Date
    April 28, 2026
    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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED AS A RESULT OF ARTERIAL SHEATH RESULTING IN ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, THE ARTERIAL SHEATH OF THE NPS WAS INSERTED OVER THE 0.035 AMPLATZ J-WIRE AND AN ANGIOGRAM WAS PERFORMED. IMAGING REVEALED THAT THE ARTERIAL SHEATH HAD CAUSED A DISSECTION IN THE COMMON CAROTID ARTERY (CCA). AN ADDITIONAL STENT WAS PLACED TO TREAT THE DISSECTION IN THE CCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143833 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306776 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention