BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE NEUROPROTECTION SYSTEM

    MDR report key: 15266846 · Received August 22, 2022

    Report

    Report Number
    3014526664-2022-00124
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    July 19, 2022
    Report Date
    August 22, 2022
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEUROPROTECTION SYSTEM (NPS) ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LED TO THE ADVERSE EVENT REPORTED. THE DEVICE RESPONSIBLE FOR THE DISSECTION WAS NOT IDENTIFIED BY THE USER. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED FAILURE IS RELATED TO THE MICROPUNCTURE KIT (MPK) OR THE ENROUTE NPS; HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. COMPLAINTS WILL CONTINUE TO BE REVIEWED AND MONITORED FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS NOTED ON THE INITIAL ANGIOGRAM FOLLOWING ENROUTE ARTERIAL SHEATH INSERTION. PER THE PHYSICIAN, A DISSECTION WAS SUSPECTED AFTER USING MICROPUNCTURE KIT (MPK), WHICH BECAME MUCH WORSE AND MORE NOTICEABLE AFTER ARTERIAL SHEATH PLACEMENT. THE PHYSICIAN ELECTED CONVERT TO CAROTID ENDARTERECTOMY (CEA). THE DEVICE RESPONSIBLE FOR THE DISSECTION WAS NOT IDENTIFIED BY THE USER. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED FAILURE IS RELATED TO THE MPK OR THE ENROUTE NEUROPROTECTION SYSTEM (NPS); HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390364 ENROUTE NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL INC. SR-200-NPS 302166 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention