BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENROUTE,ST,MOD,S,HY,US 95-014

    MDR report key: 11200985 · Received January 20, 2021

    Report

    Report Number
    3006010712-2021-00003
    Event Type
    Death
    Date Received
    January 20, 2021
    Date of Event
    January 7, 2021
    Report Date
    January 12, 2021
    Manufacturer
    BRIVANT LTD. T/A LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K160643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 0

    DURING A TCAR PROCEDURE, WHILE ATTEMPTING TO CROSS THE LESION WITH A .014 GUIDEWIRE, KUMPE ANGLE CATHEDER, .014 TRAILBLAZER WIRE, .018 TRAILBLAZER WIRE, AND GRANDSLAM WIRE, A COMMON CAROTID DISSECTION WAS NOTED AND LED THE PHYSICIAN TO COIL OFF THE INTERNAL CAROTID ARTERY TO RESOLVE THE DISSECTION. AT THIS TIME IT IS UNKNOWN IF THE REPORTED FAILURE IS RELATED TO PATIENT ANATOMY, A THIRD PARTY DEVICE USED DURING THE PROCEDURE, OR A SILK ROAD MEDICAL DEVICE FAILURE SINCE THE DISSECTION MAY HAVE BEEN CAUSED BY A COMBINATION OF GAINING ACCESS DUE TO PATIENT ANATOMY AND POSSIBLY ONE OF THE MANY WIRES THEY USED.

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 1

    DURING A TCAR PROCEDURE, WHILE ATTEMPTING TO CROSS THE LESION WITH A .014 GUIDEWIRE, KUMPE ANGLE CATHEDER, .014 TRAILBLAZER WIRE, .018 TRAILBLAZER WIRE, AND GRANDSLAM WIRE, A COMMON CAROTID DISSECTION WAS NOTED AND LED THE PHYSICIAN TO COIL OFF THE INTERNAL CAROTID ARTERY TO RESOLVE THE DISSECTION. AT THIS TIME IT IS UNKNOWN IF THE REPORTED FAILURE IS RELATED TO PATIENT ANATOMY, A THIRD PARTY DEVICE USED DURING THE PROCEDURE, OR A SILK ROAD MEDICAL DEVICE FAILURE SINCE THE DISSECTION MAY HAVE BEEN CAUSED BY A COMBINATION OF GAINING ACCESS DUE TO PATIENT ANATOMY AND POSSIBLY ONE OF THE MANY WIRES THEY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97284 ENROUTE,ST,MOD,S,HY,US 95-014 ENROUTE,ST,MOD,S,HY,US 95-014 DQX BRIVANT LTD. T/A LAKE REGION MEDICAL 901047-01 4590652

    Patients

    Seq Age Sex Outcome Treatment
    1 Death