BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENROUTE TRANSCAROTID STENT

    MDR report key: 22900384 · Received August 26, 2025

    Report

    Report Number
    2124215-2025-59714
    Event Type
    Death
    Date Received
    August 26, 2025
    Date of Event
    January 1, 2011
    Report Date
    August 26, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 - AGE AT TIME OF EVENT: THE AVERAGE AGE OF PATIENTS WHO UNDERWENT TCAR WAS 70.7 YEARS. B2 - DATE OF DEATH: AS THE FIRST REPORTED DEATHS OCCURRED WITHIN THE 30 DAYS FOLLOWING TCAR PROCEDURES, THE DEATH DATE WAS ESTIMATED TO 30 DAYS FOLLOWING THE FIRST KNOWN PROCEDURE INCLUDED IN THE STUDY. B3 - DATE OF EVENT: THE EVENT DATE WAS ESTIMATED TO THE EARLIEST KNOWN PROCEDURE INCLUDED IN THE STUDY. D6A - IMPLANT DATE: THE IMPLANT DATE WAS ESTIMATED TO THE EARLIEST KNOWN PROCEDURE INCLUDED IN THE STUDY. H6 - PATIENT CODES: E2401 WAS USED, AS THE COD WAS NOT REPORTED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. YEE, E. J., WANG, S. K., TIMSINA, L. R., RUIZ-HERRERA, S., LIAO, J. L., DONDE, N. N., FAJARDO, A. C., & MOTAGANAHALLI, R. L. (2020). PROPENSITY-MATCHED OUTCOMES OF TRANSCAROTID ARTERY REVASCULARIZATION VERSUS CAROTID ENDARTERECTOMY. JOURNAL OF SURGICAL RESEARCH, 252, 22-29. HTTPS://DOI.ORG/10.1016/J.JSS.2019.12.003.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT PATIENTS DIED WITHIN THE 10.3 MONTHS FOLLOWING THEIR RESPECTIVE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURES. THIS STUDY WAS A RETROSPECTIVE REVIEW OF PATIENTS UNDERGOING EITHER TCAR OR CAROTID ENDARTERECTOMY (CEA) PROCEDURES TO TREAT CAROTID ARTERY STENOSIS. BETWEEN JANUARY 2011 AND JULY 2018, 342 CEAS AND 109 TCARS WERE CAPTURED FOR ANALYSIS. REVIEW OF THE DATA REVEALED THAT OF THE 109 PATIENTS TREATED WITH TCAR, 2.8% OF PATIENTS DIED WITHIN 30 DAYS OF THEIR RESPECTIVE TCAR PROCEDURES. ADDITIONALLY, 4.6% OF PATIENTS DIED WITHIN 10.3 MONTHS OF THEIR RESPECTIVE TCAR PROCEDURES. THE CAUSE OF DEATH (COD) WERE NOT REPORTED FOR ANY CASE. IT WAS NOT REPORTED WHETHER THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2780127 ENROUTE TRANSCAROTID STENT STENT, CAROTID NIM SILK ROAD MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death