BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22777979 · Received August 11, 2025

    Report

    Report Number
    2124215-2025-53270
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    January 13, 2023
    Report Date
    August 11, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: THE AVERAGE AGE OF THE PATIENT COHORT WAS 72 YEARS, WITH A STANDARD DEVIATION OF 11.85 YEARS. A3B: THE FIVE PATIENTS INCLUDED IN THE STUDY WERE 2 MALES (40%) AND 3 FEMALES (60%). B3: THE EXACT EVENT DATE WAS NOT PROVIDED IN THE LITERATURE ARTICLE. THE PUBLICATION DATE OF THE ARTICLE WAS ENTERED AS THE EVENT DATE. 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. BALCENIUK, M. D., GONRING, D., WANG, M., WESTFALL, C., PORTANOVA, A., STONER, M. C., & MIX, D. S. (2023). QUANTIFICATION OF NEW INTRACEREBRAL LESIONS ON DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING AFTER TRANSCAROTID ARTERY REVASCULARIZATION FOR TREATMENT OF CAROTID ARTERY STENOSIS. JOURNAL OF VASCULAR SURGERY CASES, INNOVATIONS AND TECHNIQUES, 9(1), 101102. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2023.101102.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT PATIENTS UNDERGOING TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) USING THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) EXPERIENCED DISSECTIONS, WHICH SUBSEQUENTLY REQUIRED ADDITIONAL INTERVENTION. THE AIM OF THE STUDY WAS TO EVALUATE THE EFFECTIVENESS OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) OF TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) WITH FLOW REVERSAL BY QUANTIFYING THE INCIDENCE AND DEGREE OF NEW INTRACEREBRAL LESIONS USING DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING (DW-MRI). THE STUDY INVOLVED FIVE PATIENTS (2 ASYMPTOMATIC, 3 SYMPTOMATIC, WHO UNDERWENT RIGHT-SIDED TCAR AND RECEIVED DW-MRI SCANS BEFORE AND WITHIN 48 HOURS AFTER THE PROCEDURE TO DETECT NEW INTRACEREBRAL LESIONS. ALL FIVE PATIENTS WERE ON DUAL ANTIPLATELET THERAPY BEFORE THEIR PROCEDURE AND VERIFIED TO BE THERAPEUTIC. THE STUDY DEMONSTRATED THAT NO NEW, ACUTE POSTOPERATIVE INTRACEREBRAL LESIONS WERE OBSERVED ON DW-MRI IN PATIENTS WHO UNDERWENT TCAR. HOWEVER, ONE INTRAOPERATIVE COMPLICATION WAS REPORTED INVOLVING A DISSECTION OF THE COMMON CAROTID ARTERY AT THE ACCESS SITE OCCURRED DURING INTERVENTIONAL SHEATH INSERTION. THE DISSECTION WAS CORRECTED BY USING A LONGER STENT THAN ORIGINALLY PLANNED, EXTENDING THE STENT INTO THE COMMON CAROTID ARTERY AT THE INITIAL ACCESS SITE TO COVER THE DISSECTION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034841 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention