BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 11665301 · Received April 14, 2021

    Report

    Report Number
    3014526664-2021-00047
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 14, 2021
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED STROKE THAT INCLUDED LEFT SIDED WEAKNESS, HYPERTENSION TO 200 MMHG AND CONTROLLED FALL. THE PATIENT REQUIRED INPATIENT REHABILITATION BEFORE DISCHARGE. A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) DISPLAYED PATENT STENT, NO SIGNS OF EMBOLUS AND BLEEDING. THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561750 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL INC. SR-200-NPS 301476 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| S