BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE NEUROPROTECTION SYSTEM

    MDR report key: 13308647 · Received January 20, 2022

    Report

    Report Number
    3014526664-2022-00006
    Event Type
    Injury
    Date Received
    January 20, 2022
    Date of Event
    December 17, 2021
    Report Date
    February 17, 2022
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. ALTHOUGH THERE IS NO INDICATION THAT A MALFUNCTION OF THE SRM DEVICE OCCURRED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. SILK ROAD MEDICAL WILL CONTINUE TO MONITOR FOR OCCURRENCES OF SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    BASED ON THE ADDITIONAL INFORMATION, THE INITIAL MDR REPORT IS BEING RETRACTED AS THERE IS NO EVIDENCE THAT A SILK ROAD MEDICAL DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT AFTER COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED LEFT UPPER EXTREMITY WEAKNESS WITH NO NOTED INTERVENTION. IT WAS FURTHER REPORTED BY THE PHYSICIAN THAT THE PATIENT SUFFERED A NEW ACUTE STROKE. THE PATIENT'S CLINICAL CONDITION AFTER THE COMPLETION OF THE PROCEDURE WAS STABLE.

    Description of Event or Problem · 0

    SILK ROAD MEDICAL INC. RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PHYSICIAN DETERMINED THE NEW ACUTE STROKE WAS DUE TO ATRIAL FIBRILLATION AND UNRELATED TO THE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64370 ENROUTE NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL INC. SR-200-NPS 301975 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Disability