BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 18656005 · Received February 6, 2024

    Report

    Report Number
    3014526664-2024-00023
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 10, 2024
    Report Date
    February 6, 2024
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SECONDARY MDR WAS REPORTED UNDER 3014526664-2024-00040 AS THERE WERE TWO PRODUCTS ASSOCIATED WITH THIS EVENT. 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. AS THE REPORTED EVENT MAY RELATED TO PROCEDURAL ISSUES OR THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM NPS), THE EVENT 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 AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WAS APHASIC AND HAD AN ISCHEMIC STROKE. IMAGING REVEALED LEFT SIDED SCATTERED ACUTE INFARCTS (NEW WHITE LESIONS) AND LOW DENSITY MATERIAL WITHIN THE ENROUTE STENT THAT COULD BE POTENTIALLY THROMBUS. THE PATIENT'S SYMPTOMS HAVE NOT YET RESOLVED AND NO ADDITIONAL INTERVENTION WAS PERFORMED. AS THE REPORTED EVENT MAY RELATED TO PROCEDURAL ISSUES OR THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM NPS), THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180317 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL SR-200-NPS 305247 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Disability