BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMON NITINOL FILTER SYSTEM

    MDR report key: 1903498 · Received November 16, 2010

    Report

    Report Number
    2020394-2010-00337
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K970099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE FILTER REMAINS IMPLANTED IN THE PT AND THE DELIVERY SYSTEM WAS DISCARDED. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE DEFINITIVE ROOT CAUSE IS UNK. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: FILTER DELIVERY: ADVANCE THE FILTER BY MOVING THE NITINOL PUSHER WIRE FORWARD THROUGH THE INTRODUCER CATHETER, ADVANCING THE FILTER WITH EACH FORWARD MOTION OF THE PUSHER WIRE. DO NOT PULL BACK ON THE PUSHER WIRE, ONLY ADVANCE FORWARD WITH FILTER IN PLACE. CONTINUE FORWARD MOVEMENT OF THE PUSHER WIRE UNTIL THE FILTER ADVANCES TO THE RADIOPAQUE MARKER ON THE DISTAL END OF THE INTRODUCER CATHETER. NOTE: WITH THE FILTER POSITIONED BETWEEN THE RADIOPAQUE MARKERS OF INTRODUCER CATHETER, THE PROXIMAL END OF THE PUSHER WIRE HANDLE SHOULD BE POSITIONED AT THE TOUHY-BORST CAP OF THE Y-ADAPTER. DELIVER AND RELEASE THE FILTER: NOTE: DO NOT DELIVER THE FILTER BY PUSHING IT BEYOND THE END OF THE INTRODUCER CATHETER. INSTEAD, UNSHEATHE THE STATIONARY FILTER BY WITHDRAWING THE INTRODUCER CATHETER AS DESCRIBED ABOVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IVC FILTER LEG BECAME CAUGHT UP WITHIN THE DELIVERY SYSTEM DURING DEPLOYMENT. REPORTEDLY, THERE WAS DIFFICULTY SEPARATING THE PUSHER ROD OF THE DELIVERY SYSTEM FROM THE FILTER. ONCE THE FILTER SEPARATED FROM THE DELIVERY SYSTEM, THE FILTER WAS AT THE LEVEL OF THE ILIAC BIFURCATION, COVERING THE RIGHT ILIAC VEIN, WITH ONE LEG EXTENDING OVER THE LEFT COMMON ILIAC. ADDITIONAL ACCESS WAS MADE IN THE IJ AND ANOTHER MANUFACTURER'S IVC FILTER WAS THEN IMPLANTED ABOVE THE FIRST FILTER WITHOUT INCIDENT. THE PT IS REPORTED TO BE ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMON NITINOL FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. GFUC1708

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention