BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 12598168 · Received October 8, 2021

    Report

    Report Number
    3006010712-2021-00034
    Event Type
    Death
    Date Received
    October 8, 2021
    Date of Event
    September 1, 2021
    Report Date
    October 8, 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
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION UNDERWAY AND BE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TCAR PROCEDURE, UPON 0.014" GUIDEWIRE INSERTION, A DISSECTION WAS NOTED. THE PHYSICIAN ALSO USED THE SAME PLANNED STENT TO COVER THE DISSECTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021 SILK ROAD MEDICAL WAS INFORMED THAT A FEW WEEKS FOLLOWING A TCAR PROCEDURE, THIS PATIENT SUFFERED A HEMORRHAGIC STROKE, BLOOD PRESSURE ISSUES, WAS ADMITTED INTO THE EMERGENCY ROOM AND THE PATIENT UNFORTUNATELY EXPIRED.

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TCAR PROCEDURE, UPON 0.014" GUIDEWIRE INSERTION, A DISSECTION WAS NOTED. THE PHYSICIAN ALSO USED THE SAME PLANNED STENT TO COVER THE DISSECTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021 (B)(6) MEDICAL WAS INFORMED THAT A FEW WEEKS FOLLOWING A TCAR PROCEDURE, THIS PATIENT SUFFERED A HEMORRHAGIC STROKE, BLOOD PRESSURE ISSUES, WAS ADMITTED INTO THE EMERGENCY ROOM AND THE PATIENT UNFORTUNATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497946 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 6150253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| D