BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22866030 · Received August 21, 2025

    Report

    Report Number
    2124215-2025-57038
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    January 1, 2016
    Report Date
    August 21, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE EXACT EVENT DATE WAS NOT PROVIDED IN THE LITERATURE ARTICLE. THE DATE OF EVENT WAS ESTIMATED USING THE BEGINNING OF THE STUDY PERIOD DATE RANGE, WHICH IS JANUARY 2016 TO AUGUST 2019. DETAILS OF THE EVENT, INCLUDING PRODUCT INFORMATION, WERE NOT PROVIDED TO BSC. BECAUSE THE PRODUCT LOT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) NUMBER AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WANG, S. K., SEVERANCE, S., WESTIN, G. G., MAIJUB, J. G., GUPTA, A. K., SAWCHUK, A. P., FAJARDO, A. C., & MOTAGANAHALLI, R. L. (2020). PERIOPERATIVE AND 1-YEAR TRANSCAROTID REVASCULARIZATION OUTCOMES IN SYMPTOMATIC PATIENTS. JOURNAL OF VASCULAR SURGERY, 72(6), 2047-2053. HTTPS://DOI.ORG/10.1016/J.JVS.2020.03.044.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT PATIENTS EXPERIENCED ADVERSE EVENTS AND ADDITIONAL INTERVENTION IN THE PERIOPERATIVE PERIOD FOLLOWING THEIR RESPECTIVE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURES. THIS STUDY EVALUATED THE PERIOPERATIVE (30-DAY) AND 1-YEAR OUTCOMES OF TCAR AMONG 167 PATIENTS FROM JANUARY 2016 TO AUGUST 2019. 82 PATIENTS WERE CLASSIFIED AS SYMPTOMATIC, DEFINED BY A HISTORY OF UNILATERAL TRANSIENT ISCHEMIC ATTACK OR STROKE ATTRIBUTABLE TO AN EXTRACRANIAL CAROTID ARTERY LESION WITHIN THE PREVIOUS 180 DAYS, AND 85 WERE CLASSIFIED AS ASYMPTOMATIC. THE DEMOGRAPHIC CHARACTERISTICS BETWEEN THE TWO GROUPS WERE LARGELY SIMILAR, ALTHOUGH SYMPTOMATIC PATIENTS WERE SIGNIFICANTLY MORE LIKELY TO BE FEMALE (28.0% VS. 9.4%). THE AVERAGE AGE ACROSS ALL PATIENTS WAS APPROXIMATELY 71 YEARS. PERIOPERATIVE OUTCOMES SHOWED THE STROKE RATE AS 1.2% IN SYMPTOMATIC PATIENTS VERSUS 2.4% IN ASYMPTOMATIC ONES. AT THE 1-YEAR FOLLOW-UP, SYMPTOMATIC PATIENTS HAD SLIGHTLY HIGHER RATES OF IPSILATERAL STROKE (3.7% VS. 0%) AND STENT THROMBOSIS (3.7% VS. 0%). IN-STENT RESTENOSIS GREATER THAN 50% OCCURRED IN 1.9% OF SYMPTOMATIC PATIENTS. THREE ASYMPTOMATIC PATIENTS REQUIRED REINTERVENTION PRIOR TO HOSPITAL DISCHARGE, ALL FOR AIRWAY CONCERNS RELATED TO EXPANDING POSTOPERATIVE HEMATOMAS WITHOUT AN IDENTIFIABLE BLEEDING VESSEL UPON REOPERATION. ONE PATIENT EXPERIENCED CRANIAL NERVE INJURY INVOLVING THE VAGUS NERVE, LIKELY SECONDARY TO TRACTION, WHICH RESOLVED BY THE FIRST POSTOPERATIVE CLINIC VISIT. RENAL FAILURE OCCURRED IN ONLY 0.6% OF THE TOTAL PATIENT POPULATION (IN A SYMPTOMATIC PATIENT). AT THE 1-YEAR FOLLOW-UP, AMONG THE 114 PATIENTS WITH AVAILABLE DATA, MYOCARDIAL INFARCTION (MI) OCCURRED IN JUST ONE PATIENT (0.9%) IN THE ASYMPTOMATIC GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877161 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R