BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENROUTE 0.014" GUIDEWIRE

    MDR report key: 11263880 · Received February 1, 2021

    Report

    Report Number
    3014526664-2021-00013
    Event Type
    Death
    Date Received
    February 1, 2021
    Date of Event
    January 6, 2021
    Report Date
    February 1, 2021
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    UDI-DI
    00811311020546
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A TRANSCAROTID ARTERY REVASCULARIZATION (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/PERFORATION WAS NOTED. THERE WAS OBSTRUCTED FLOW WHEN THE 9X40 STENT WAS PLACED. AFTER POST DIALATING WITH A 4.5 BALLOON, AN IMAGE WAS TAKEN, HOWEVER, THE PERFORATION WAS NOTED. THIS EVENT LED THE PHYSICIAN TO COIL OFF THE ICA TO RESOLVE THE PERFORATION. AFTER THE PROCEDURE, THE PHYSICIAN INFORMED THE FAMILY THAT THE PATIENT HAD 90% STENOSIS INITIALLY, AND NOW THE PATIENT WAS AT 100% STENOSIS. SILK ROAD MEDICAL INC. WAS NOTIFIED THAT THE PATIENT EXPIRED ON (B)(6) 2021. THE BAIL OUT THERAPY FOR THE EXTENSIVE CAROTID DISSECTION, NAMELY THERAPEUTIC ACUTE OCCLUSION OF THE ICA WITH ENDOVASCULAR COILS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENTS DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153588 ENROUTE 0.014" GUIDEWIRE 0.014" GUIDEWIRE DQX LAKE REGION MEDICAL SR-014-GW 4590652 00811311020546

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R