BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIA 27 MICROCATHETER

    MDR report key: 6954846 · Received October 17, 2017

    Report

    Report Number
    3008423090-2017-00002
    Event Type
    Death
    Date Received
    October 17, 2017
    Date of Event
    September 20, 2017
    Report Date
    October 16, 2017
    Manufacturer
    SEQUENT MEDICAL INC., ALISO VIEJO, CA
    Product Code
    KRA
    PMA / PMN Number
    K132652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MICROCATHETER VIA 27 WAS DELIVERED INTO THE ANEURYSM SACK AT THE ACOM. AS THE WEB-DEVICE WAS ADVANCED THROUGH THE MICROCATHETER, SUDDENLY THE DISTAL TIP OF THE MICROCATHETER MOVED FORWARD AND PERFORATED THE ANEURYSM DOME. THE CONSTRAINED WEB DEVICE WITHIN THE MICROCATHETER AT THIS TIME HAS BEEN AROUND THE A1 SEGMENT. THE MICROCATHETER AND THE WHOLE TRI-AXIAL CATHETER SYSTEM HAS BEEN BROUGHT BACK IN RIGHT POSITION. DELIVERY OF THE WEB DEVICE HAS BEEN CONTINUED. AFTER UNSHEATHING THE WEB AND HAVING IT PROPERLY OPENED IN RIGHT POSITION CONTROL ANGIOGRAM HAS BEEN PERFORMED, SHOWING BLEEDING OUT OF THE ANEURYSM SACK. DECISION TO DETACH THE WEB HAS BEEN MADE AND DETACHMENT HAS BEEN PERFORMED PROPERLY WITHOUT ANY PROBLEMS. AT THIS STAGE OF THE PROCEDURE NUMEROUS ATTEMPTS TO STOP THE BLEEDING HAS BEEN PERFORMED: USING 2 SCEPTER OCCLUSION BALLOONS, FILLING SPACES AROUND THE IMPLANT WITH ONYX, COILING AT THE RESIDUAL NECK PROXIMAL OF THE WEB 2 EVD AS EMERGENCY RESCUE ACTIVITY HAS BEEN PERFORMED IN ANGIO SUITE BY NEUROSURGERY TEAM. SEQUENT PERSONNEL SPOKE WITH PHYSICIANS AFTER THE CASE AND DISCUSSED THE DIFFICULT GUIDEWIRE/CATHETER ACCESS OF THE ANEURYSM AND SUBSEQUENT BUILD-UP OF TENSION IN THE MICRO-CATHETER SYSTEM (NEURONMAX, CAT 6F, VIA27) DURING WEB DELIVERY (FRICTION/RESISTANCE AT THE M1/A1 JUNCTION) THAT LED TO CATHETER MOVEMENT AND PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734442 VIA 27 MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC., ALISO VIEJO, CA VIA 27-154-01 17050502

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death