BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 18419840 · Received December 29, 2023

    Report

    Report Number
    3014526664-2023-00223
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    November 13, 2023
    Report Date
    December 29, 2023
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LED TO THE ADVERSE EVENT REPORTED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED FAILURE IS RELATED TO A SILK ROAD MEDICAL DEVICE FAILURE OR A RECRUDESCENCE OF ORIGINAL EVENT. AS THIS EVENT COULD BE ASSOCIATED WITH THE NPS, IT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION. SILK ROAD MEDICAL WILL CONTINUE TO MONITOR FOR OCCURRENCES OF SIMILAR EVENTS. 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 HOURS AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED STROKE SYMPTOMS. IMAGING REVEALED AN EMBOLIC STROKE. THE PATIENT'S SYMPTOMS HAVE COMPLETELY RESOLVED HOWEVER IT IS UNKNOWN HOW LONG THE SYMPTOMS LASTED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED FAILURE IS RELATED TO A SILK ROAD MEDICAL DEVICE FAILURE OR A RECRUDESCENCE OF ORIGINAL EVENT. AS THIS EVENT COULD BE ASSOCIATED WITH THE NPS, IT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708774 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL SR-200-NPS 305141 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other