BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE NPS

    MDR report key: 10505227 · Received September 8, 2020

    Report

    Report Number
    3014526664-2020-00081
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 8, 2020
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NTE
    PMA / PMN Number
    K153485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 THE MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LEAD TO THE ADVERSE EVENT REPORTED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. SILK ROAD MEDICAL WILL CONTINUE TO MONITOR FOR OCCURRENCES OF RELATED EVENTS. OUT OF AN ABUNDANCE OF CAUTION, THIS COMPLAINT IS BEING REPORTED AS IT IS UNCLEAR IF THE ADVERSE EVENT WAS CAUSED BY THE PROCEDURE, A PATIENT RESPONSE, OR THE DEVICE. A SECONDARY MDR IS SUBMITTED UNDER 3500A FORM # 3014526664-2020-00080 SINCE AT THIS TIME IT IS UNKNOWN WHICH DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. UPON REMOVAL OF ENROUTE ARTERIAL SHEATH PROTAMINE WAS REQUESTED BY THE PHYSICIAN. AFTER THE ACCESS SITE WAS CLOSED, THE PATIENT WAS AWAKE, ABLE TO SPEAK AND MOVE ARMS AND LEGS. THE PATIENT THEN BECAME HYPOTENSIVE, TACHYCARDIC, AND ITCHY. THE ANESTHESIOLOGIST STARTED EPINEPHRINE DRIP TO STABILIZE THE PATIENT AND THE PATIENT WAS ABLE TO RESPOND TO ALL COMMANDS WITH ALL EXTREMITIES. LATER THAT SAME DAY, THE PATIENT WAS NOT MOVING HER LEFT SIDE AND RECEIVED A CT SCAN WITH CONTRAST. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM TO HAVE THE ENROUTE STENT REMOVED. THE PATIENT'S STATUS DID NOT CHANGE POST EXPLANT, AND THE PATIENT EXPERIENCED SEIZURES AND INTRAPARENCHYMAL BLEEDS OVERNIGHT. THE FOLLOWING DAY, THE PATIENT WAS SPEAKING AND ABLE TO MOVE HER LEFT LEG. A VIDEO REVIEW WAS PERFORMED AFTER THE TCAR PROCEDURE THAT SHOWED STENT COMPRESSION AT THE PROXIMAL INTERNAL CAROTID ARTERY (ICA) WITH WHAT APPEARED TO BE MURAL THROMBUS IN THE DISTAL END OF THE STENT. THE ANGIOGRAMS TAKEN FROM FEMORAL ARTERY ACCESS DURING RE-INTERVENTION SHOWED THE STENT PATENT WITH APPROXIMATELY 30-50% RESIDUAL STENOSIS. THE PHYSICIAN'S PARTNER BELIEVED THE THROMBUS WAS PERHAPS DUE TO PROTAMINE. THE ANESTHESIOLOGIST BELIEVED THE PATIENT HAD A SUBSTANTIAL PROTAMINE REACTION DURING THE TCAR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965343 ENROUTE NPS TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL INC. SR-200-NPS 301091

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention