BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS

    MDR report key: 2608877 · Received June 6, 2012

    Report

    Report Number
    2183460-2012-00007
    Event Type
    Other
    Date Received
    June 6, 2012
    Date of Event
    May 16, 2012
    Report Date
    June 6, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF ARTERIALEMBOLISM DURING A JETSTREAM PROCEDURE. THE PATIENT IS A FEMALE OF UNKNOWN AGE AND UNKNOWN MEDICAL HISTORY. THE PATIENT PRESENTED WITH A SINGLE VESSEL RUN-OFF TO THE MID-ANTERIOR TIBIAL WITH CHRONIC TOTAL OCCLUSION (CTO) OF THE SUPERFICIAL FEMORAL ARTERY (SFA). SLOW FLOW WAS NOTED AFTER DEBULKING OF THE SFA DOWN TO THE ABDUCTOR CANAL WITH THE JETSTREAM NAVITUS DEVICE (NAVITUS). TWO MINUTES INTO ARTHRECTOMY OF THE SFA USING THE NAVITUS BLOOD STOPPED FLOWING THROUGH THE RETURN TUBING OF THE NAVITUS. THE NAVITUS WAS RETRACTED AND REPRIMED IN A BOWL OF HEPARINIZED SALINE. DURING PRIMING FLUID WAS FLOWING THROUGH THE RETURN TUBING AND THE PRIMING OF THE DEVICE WAS COMPLETED. THE NAVITUS WAS REENTERED INTO THE VESSEL OVER THE JET-WIRE AND DEBULKING WAS CONTINUED WITH THE SAME RESULTS WHEN ADVANCED THROUGH THE LESION (NO BLOOD RETURNING THROUGH THE TUBING). THE PROCEDURE CONTINUED AND THE DEVICE WAS ADVANCED SLOWLY; ONE MM/SECOND UNTIL THE DISTAL CAP OF THE CTO WAS PENETRATED. ANGIOGRAPHY WAS PERFORMED WHICH SHOWED VERY SLOW BLOOD FLOW. A 200 MM BALLOON WAS THEN USED BUT THERE WAS NO IMPROVEMENT IN BLOOD FLOW. A 150 MM STENT WAS THEN PLACED IN THE HUNTERS CANAL. A MANUAL ASPIRATION CATHETER WAS USED BUT COULD NOT BE ADVANCED TO THE DESIRED DISTAL LOCATION. THE PATIENT WAS COMPLAINING OF PAIN AND THE PROCEDURE WAS STOPPED. A VASCULAR SURGEON THEN DETERMINED THAT SURGERY WAS NECESSARY TO PERFORM A BYPASS. THE PATIENT WAS TRANSFERRED TO SURGERY AND BYPASS WAS PERFORMED. THE SURGEON DETERMINED THAT AN ARTERIALEMBOLISM WAS DEFINITE BUT COULD NOT DETERMINE WHEN IT OCCURRED. THIS EVENT IS CONSIDERED REPORTABLE AS THE ASSOCIATED BETWEEN THE JETSTREAM DEVICE AND THE NOTED ARTERIALEMBOLISM EVENT CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH SINGLE VESSEL RUN-OFF TO MID- ANTERIOR TIBIAL; CTO OF SFA. SLOW FLOW AFTER DEBULKING OF SFA DOWN TO ABDUCTOR CANAL. TWO MINUTES INTO ATHERECTOMY OF THE SFA BLOOD STOPPED FLOWING THROUGH RETURN TUBING OF NAVITUS. DEVICE WAS RETRACTED AND REPRIMED INTO BOWL OF HEPARINIZED SALINE ON BACK TABLE. FLUID WAS RETURNING THROUGH TUBING AND PRIME COMPLETE. REENTERED VESSEL OVER JET-WIRE, AND DEBULKING WAS CONTINUED WITH SAME RESULT WHEN ADVANCED THROUGH LESION (NO BLOOD RETURNING THRU TUBING); PROCEDURE CONTINUED AND DEVICE ADVANCED SLOWLY; ONE MM / SEC. UNTIL DISTAL CAP OF CTO WAS PURCHASED. ANGIOGRAPHY PERFORMED AND VERY SLOW FLOW DETERMINED. A 200MM BALLOON WAS THEN USED TO NO AVAIL; A 150MM STENT WAS THEN PLACED IN THE HUNTERS CANAL; A MANUAL ASPIRATION CATHETER WAS USED AND COULD NOT BE ADVANCED TO DESIRED DISTAL LOCATION. PATIENT WAS COMPLAINING OF PAIN; PROCEDURE WAS STOPPED. VASCULAR SURGEON THEN DETERMINED THAT SURGERY WAS NECESSARY TO PERFORM A BYPASS. PATIENT WAS TRANSFERRED TO SURGERY AND BYPASS PERFORMED. SURGEON DETERMINED THAT ARTERIALEMBOLISM WAS DEFINITE; BUT COULDN'T SAY WHEN IT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM NAVITUS JETSTREAM NAVITUS MCW BAYER INTERVENTIONAL, INC NAVITUS 120216

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention