BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 21170299 · Received January 16, 2025

    Report

    Report Number
    3014526664-2025-00004
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 16, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    PMA / PMN Number
    K230402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT 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. THIS EVENT IS AN OFF-LABEL USAGE OF THE NPS DEVICE WHICH LED TO THE EMBOLIC EVENT AND WILL BE REPORTED. COMPLAINTS WILL CONTINUE TO BE REVIEWED AND MONITORED FOR TRENDS. ALL REASONABLY AVAILABLE INFORMATION HAS BEEN PROVIDED BY THE COMPANY AT THE TIME OF SUBMISSION OF THIS REPORT. THE FIELDS THAT ARE BLANK ARE NOT AN OMISSION AND INDICATE THAT THE INFORMATION IS EITHER NOT APPLICABLE OR CURRENTLY UNAVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT FAILED THE POST-PROCEDURE NEUROLOGICAL CHECK AND COULD NOT MOVE THEIR RIGHT ARM. IMAGING REVEALED AN EMBOLIC EVENT AND AN OCCLUSION WAS NOTED IN THE M2 SEGMENT. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHERE A THROMBECTOMY WAS ATTEMPTED WITH A TRANSFEMORAL APPROACH, AND THE PATIENT EXPERIENCED A SUBARACHNOID BLEED. THE TRANSFEMORAL PROCEDURE WAS ABORTED. THE PATIENT PASSED AWAY TWO DAYS LATER DUE TO A CARDIAC ARREST. ADDITIONAL INFORMATION STATED THAT THE PATIENT HAD SEVERE UNDERLYING CARDIOMYOPATHY AND POORLY CONTROLLED BLOOD PRESSURE. THE SILK ROAD EXECUTIVE MEDICAL DIRECTOR (EMD) EVALUATED THE INFORMATION AND CONCLUDED THAT THE EMBOLIC EVENT AND ISCHEMIC STROKE WERE DUE TO OFF-LABEL USAGE. IMAGING REVEALED THE ACCESS LENGTH TO BE 3.3 CM AND THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) INSTRUCTION FOR USE (IFU) INDICATES THE NPS DEVICE FOR USE IN PATIENTS WITH THE ACCESS LENGTH BEING "A MINIMUM OF 5 CM ABOVE THE CLAVICLE AS MEASURED BY DUPLEX DOPPLER ULTRASOUND (DUS) OR COMPUTERIZED AXIAL TOMOGRAPHY (CT) ANGIOGRAPHY OR MAGNETIC RESONANCE (MR) ANGIOGRAPHY" TO PROVIDE AN ADEQUATE RUNWAY TO PERFORM THE PROCEDURE. DUE TO THE SHORTER RUNWAY, THE PHYSICIAN MISJUDGED THE POSITION OF THE J-WIRE OF THE NPS WHEN TRYING TO STOP SHORT AND ENGAGED THE LESION WITHOUT ACTIVATION OF FLOW REVERSAL, LEADING TO THE EMBOLIC EVENT. THE REPORTED SUBARACHNOID HEMORRHAGE WAS ASSOCIATED WITH THE MECHANICAL THROMBECTOMY AND NOT RELATED TO THE TCAR PROCEDURE. ADDITIONALLY, THE REPORTED CARDIAC ARREST AND DEATH WERE RELATED TO THE PATIENT'S UNDERLYING CONDITION (SEVERE CARDIOMYOPATHY) AND NOT RELATED TO A SILK ROAD MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510532 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL 306079 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Disability