BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22841677 · Received August 19, 2025

    Report

    Report Number
    2124215-2025-56384
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    December 1, 2015
    Report Date
    August 19, 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

    A2: THE MEAN AGE OF 70.4, WITH A STANDARD DEVIATION OF 9.7 YEARS, WHILE THOSE IN THE HOSTILE FIELD GROUP HAD A MEAN AGE OF 69.0, WITH A STANDARD DEVIATION OF 8.7 YEARS. A3B: WOMEN COMPRISED 15.1% OF THE VIRGIN FIELD GROUP AND 30.0% OF THE HOSTILE FIELD GROUP. 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 COVERED DECEMBER 2015 TO APRIL 2019. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BOSTON SCIENTIFIC. BASED ON THE NATURE OF THE INFORMATION RECEIVED, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE DEVICE IDENTIFIER (UDI) OR OTHER PRODUCT-SPECIFIC DETAILS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WANG, S. K., MILADORE, J. N., DRUCKER, N. A., FAJARDO, A., LEMMON, G. W., DALSING, M. C., MURPHY, M. P., & MOTAGANAHALLI, R. L. (2019). PROCEDURAL COMPLEXITY OF TRANSCAROTID ARTERY REVASCULARIZATION IS NOT INCREASED IN IRRADIATED AND REOPERATIVE NECKS. ANNALS OF VASCULAR SURGERY, 61, 212-217. HTTPS://DOI.ORG/10.1016/J.AVSG.2019.05.063.

    Description of Event or Problem · 0

    THE STUDY COMPARED PERIOPERATIVE AND POSTOPERATIVE COMPLICATIONS OF TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURES PERFORMED BETWEEN DECEMBER 2015 AND APRIL 2019 BETWEEN PATIENTS WITH VIRGIN NECKS AND THOSE WITH HOSTILE NECKS, DEFINED AS HAVING UNDERGONE PRIOR NECK RADIATION OR SURGERY. ALL TCAR PROCEDURES PERFORMED AT AFFILIATED FACILITIES BETWEEN DECEMBER 2015 AND APRIL 2019 WERE CAPTURED. SEVENTY OF THE PROCEDURES WERE PERFORMED AS PART OF THE ONGOING ROADSTER 2 REGISTRY AND WERE EXCLUDED, LEAVING 149 TOTAL INTERVENTIONS FOR ANALYSIS. OF THE REMAINING TCARS, 30 WERE PERFORMED IN PATIENTS WITH A HISTORY OF PREVIOUS IPSILATERAL NECK DISSECTION OR RADIATION TREATMENT. AMONG THESE PATIENTS, 10 HAD UNDERGONE PRIOR NECK RADIATION, 23 HAD EXPERIENCED PREVIOUS SURGICAL DISSECTION (3 ONCOLOGIC AND 20 CAROTID ENDARTERECTOMY), AND 3 HAD UNDERGONE BOTH RADIATION AND SURGICAL DISSECTION. THE REMAINING 119 PATIENTS DID NOT REPORT ANY PRIOR NECK INTERVENTIONS BEFORE THE INDEX TCAR. NO DIFFERENCES WERE OBSERVED IN BASELINE COMORBIDITIES OR MEDICATION USAGE BETWEEN THE TWO COHORTS. PATIENTS INVOLVED IN THE STUDY HAD AN IPSILATERAL TRANSIENT ISCHEMIC ATTACK (TIA) OR IPSILATERAL STROKE WITHIN THE PREVIOUS 180 DAYS IN THE PRESENCE OF A STENOSIS GREATER THAN 50% OR WERE ASYMPTOMATIC WITH STENOSIS GREATER THAN 80% ON CAROTID DUPLEX OR COMPUTED TOMOGRAPHY ANGIOGRAM. IN THIS STUDY, PATIENTS IN THE VIRGIN FIELD GROUP HAD A MEAN AGE OF 70.4, WITH A STANDARD DEVIATION OF 9.7 YEARS, WHILE THOSE IN THE HOSTILE FIELD GROUP HAD A MEAN AGE OF 69.0, WITH A STANDARD DEVIATION OF 8.7 YEARS. WOMEN COMPRISED 15.1% OF THE VIRGIN FIELD GROUP AND 30.0% OF THE HOSTILE FIELD GROUP. WITHIN 30 DAYS POST-PROCEDURE, THE RATE OF IPSILATERAL STROKE WAS 2.5% IN VIRGIN NECKS AND 0% IN HOSTILE NECKS. CRANIAL NERVE PALSY OCCURRED ONLY IN THE HOSTILE NECK GROUP (3.3%). HEMATOMAS REQUIRING REINTERVENTION WERE OBSERVED IN BOTH GROUPS, TWO IN VIRGIN NECKS AND ONE IN A HOSTILE NECK. OVERALL REINTERVENTION RATES WERE LOW AND COMPARABLE (1.7% IN VIRGIN VS. 3.3% IN HOSTILE). THE FOLLOW-UP PERIOD AVERAGED 7.5 MONTHS FOR VIRGIN NECKS AND 10.4 MONTHS FOR HOSTILE NECKS. DURING THIS TIME, THE VIRGIN NECK GROUP EXPERIENCED ONE ADDITIONAL IPSILATERAL STROKE, ONE STENT STENOSIS, AND ONE STENT THROMBOSIS. IN THE HOSTILE NECK GROUP, ONE PATIENT DEVELOPED DYSPHONIA AND DIFFICULTY SWALLOWING, SYMPTOMS INDICATIVE OF POSSIBLE RECURRENT LARYNGEAL NERVE INVOLVEMENT. THE PATIENT'S SYMPTOMS FULLY RESOLVED BY THE ONE-MONTH FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253521 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O