BEUDAMED
    FDA Adverse Event Death Summary report: N

    JETSTREAM NAVITUS L

    MDR report key: 2612674 · Received June 1, 2012

    Report

    Report Number
    2183460-2012-00006
    Event Type
    Death
    Date Received
    June 1, 2012
    Date of Event
    May 16, 2012
    Report Date
    June 1, 2012
    Manufacturer
    BAYER INTERVENTIONAL INC
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF PT DEATH DURING A JETSTREAM PROCEDURE. THE PT IS A (B)(6) MALE WHO PRESENTED WITH SEVERE PERIPHERAL ARTERIAL DISEASE. THE PHYSICIAN IDENTIFIED LARGE AMOUNTS OF CALCIUM FROM THE ILIACS DOWN THROUGH THE SUPERFICIAL FEMORAL ARTERY (SFA). USING IVUS THE PHYSICIAN OBSERVED APPROX 9 MM OF CALCIUM IN THE 11 MM VESSEL IN THE ILIAC. WITH THE WIRE AND CATHETER TIP UP AND OVER THE BIFURCATION THE PHYSICIAN LOADED THE NAVITUS L ATHERECTOMY DEVICE. THE PHYSICIAN MADE 2 PASSES THROUGH THE ILIACS BLADES DOWN ON THE DEVICE. THE PHYSICIAN THEN MADE A SECOND PASS, WHEN HE NOTICED THAT THE WIRE BUCKLED AND THAT THE PT'S PRESSURES BEGAN TO DROP. THE PHYSICIAN IMMEDIATELY WITHDREW THE JETSTREAM DEVICE AND REQUESTED A COVERED STENT, BALLOONS, UNITS OF BLOOD AND OTHER ORDERS. A VASCULAR SURGEON WAS PAGED AND UNITS OF BLOOD WERE GIVEN ALONG WITH CHEST COMPRESSIONS. AFTER APPROX 20 - 25 MINUTES, THE PT WAS PRONOUNCED DEAD. THE IFU INDICATION STATEMENT IS: THE JETSTREAM SYS IS INTENDED FOR USE IN ATHERECTOMY OF THE PERIPHERAL VASCULATURE AND TO BREAK APART AND REMOVE THROMBUS FROM UPPER AND LOWER EXTREMITY PERIPHERAL ARTERIES. IT IS NOT INTENDED FOR USE IN CORONARY, CAROTID, ILIAC OR RENAL VASCULATURE. IN ADDITION, THE IFU HAS THE FOLLOWING CAUTION STATEMENTS REGARDING GUIDEWIRE USE: "USE ONLY LISTED COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM NAVITUS L SYS. USE OF ANY SUPPLIES NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM NAVITUS SYS." "OPERATING THE CATHETER OVER A KINKED GUIDEWIRE MAY CAUSE VESSEL DAMAGE OR GUIDEWIRE FRACTURE." "DURING TREATMENT, DO NOT ALLOW CATHETER TIP WITHIN 10.0 CM OF SPRING TIP PORTION OF THE GUIDEWIRE. INTERACTION BETWEEN THE CATHETER TIP AND THIS PORTION OF THE GUIDEWIRE MAY CAUSE DAMAGE TO OR DETACHMENT OF THE TIP OR COMPLICATE GUIDEWIRE MGMT." "THE GUIDEWIRE MUST BE IN PLACE PRIOR TO OPERATING THE JETSTREAM NAVITUS L CATHETER IN THE PT. ABSENCE OF THE GUIDEWIRE MAY LEAD TO INABILITY TO STEER THE CATHETER AND CAUSE POTENTIAL VESSEL DAMAGE." "IF THE GUIDEWIRE IS ACCIDENTLY RETRACTED INTO THE DEVICE DURING PLACEMENT OR TREATMENT, STOP USE, AND REMOVE THE JETSTREAM NAVITUS L CATHETER AND THE GUIDEWIRE FROM THE PT. VERIFY THAT THE GUIDEWIRE IS NOT DAMAGED BEFORE RE-INSERTING THE GUIDEWIRE. IF DAMAGE IS NOTICED, REPLACE THE GUIDEWIRE." "HOLD THE GUIDEWIRE FIRMLY DURING CATHETER RETRACTION PROCESS. FAILURE TO DO SO MAY RESULT IN GUIDEWIRE ROTATION WITHIN THE VESSEL." THE EXACT CAUSE WHICH RESULTED IN THE PT'S DEATH IS NOT DOCUMENTED IN THE COMPLAINT REPORT BUT IT IS POSSIBLE THAT THE CAUSE OF DEATH WAS A VESSEL PERFORATION OF THE ILIAC ARTERY. AS STATED IN THE INDICATION STATEMENT, TREATMENT IN THE ILIAC IS OFF-LABEL. THIS EVENT IS CONSIDERED REPORTABLE AS THE ASSOCIATION BETWEEN THE JETSTREAM DEVICE AND THE NOTED EVENT WHICH LED TO THE PT'S DEATH CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    THE PT PRESENTED WITH SEVERE PERIPHERAL ARTERIAL DISEASE. DR (B)(6) IDENTIFIED LARGE AMOUNTS OF CALCIUM FROM THE ILIACS DOWN THROUGH THE SFA. ON IVUS, HE OBSERVED APPROX 9 MM OF CALCIUM IN THE 11 MM VESSEL OF THE ILIAC. WITH THE WIRE AND CATHETER UP AND OVER THE BIFURCATION, HE LOADED THE NAVITUS L. HE MADE 2 PASSES THROUGH THE ILIACS, BLADES DOWN. ON THE SECOND PASS, HE NOTICED THAT THE WIRE BUCKLED AND THAT THE PT PRESSURES BEGAN TO DROP. HE IMMEDIATELY WITHDREW THE DEVICE AND YELLED FOR A COVERED STENT, BALLOONS, UNITS OF BLOOD, ETC. I WAS NOT IN THE ROOM WHEN THE EVENT OCCURRED, I WAS UNAWARE THAT HE WAS CONSIDERING JETSTREAM IN THE ILIAC. THE OPERATING ROOM WAS CALLED AND A VASCULAR SURGEON WAS PAGED, UNITS OF BLOOD WERE GIVEN, CHEST COMPRESSIONS STARTED. AFTER APPROX 20 -25 MINUTES, THE PT WAS PRONOUNCED DEAD IN THE (B)(6). THE PRODUCT WAS RETAINED BY THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM NAVITUS L JETSTREAM NAVITUS L MCW BAYER INTERVENTIONAL INC NAVITUS L UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death