BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2143503 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04558
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE EMBOLIC PROTECTION SYSTEM (EPS) WAS RETURNED WITH BLOOD AND TISSUE IN THE FILTRATION ELEMENT, CONSISTENT WITH THE REPORTED USE AND ENTANGLEMENT IN THE ANATOMY. THERE WAS NO SALINE VISIBLE. THE BAREWIRE WAS RETURNED LOADED IN THE DELIVERY CATHETER BUT THE FILTRATION ELEMENT WAS NOT LOADED IN THE POD. THE PUSHER WAS PUSHED OUT. THERE WAS A BEND IN THE CORE 1 CM PROXIMAL TO THE TIP BALL, CONSISTENT WITH HANDLING OR TIP SHAPING. THERE WAS A KINK IN THE SHAFT AT THE DISTAL END OF THE HANDLE, LIKELY DUE TO MANIPULATION OF THE DEVICE DURING THE REPORTED ENTANGLEMENT. THERE WAS NO OTHER DAMAGE NOTED TO THE EPS. THE TORQUE DEVICE, RED CLIP, AND TRAY WERE NOT RETURNED. THE TIP OF THE BAREWIRE WAS TUGGED TO CONFIRM THAT THE CORE WAS INTACT. MIGRATION OF THE FILTER CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, DEVICE PLACEMENT TECHNIQUE, ACCESSORY DEVICE SUPPORT, AND FAILURE TO MAINTAIN FILTER PLACEMENT DURING ADVANCEMENT/REMOVAL OF DEVICES OVER THE BAREWIRE. THE EMBOSHIELD NAV6 INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING PRECAUTIONS: MAINTAIN PROPER GUIDING CATHETER/SHEATH SUPPORT IN THE COMMON CAROTID ARTERY THROUGHOUT THE PROCEDURE. ENSURE THAT THERE IS ADEQUATE DISTANCE BETWEEN THE PROXIMAL TIP OF THE FILTRATION ELEMENT AND THE MOST DISTAL TIP OF ANY INTERVENTIONAL DEVICE TO BE INTRODUCED OVER THE FILTER DELIVERY WIRE TO AVOID ENGAGEMENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL SAMPLES MET ALL MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR FILTER MIGRATION, DIFFICULT TO REMOVE, BENDS OR KINKS FOR THIS LOT. OVERALL, THE REPORTED DIFFICULTIES AND SUBSEQUENT DAMAGE APPEAR TO BE RELATED TO CASE CIRCUMSTANCES, AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. AS PART OF THE MANUFACTURING QUALITY PROCESS, ALL EMBOLIC PROTECTION DEVICES ARE VISUALLY INSPECTED FOR DAMAGE. IN ADDITION, A SAMPLING OF UNITS IS VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED. THE FILTER MIGRATION AND ENTANGLEMENT APPEAR TO BE RELATED TO FAILURE TO MAINTAIN FILTER PLACEMENT DURING REMOVAL OF THE DELIVERY CATHETER. IN THIS CASE, THE DIFFICULTIES APPEAR TO BE RELATED TO CASE CIRCUMSTANCES AND NOT NECESSARILY USER RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE NAV6 EMBOSHIELD EMBOLIC PROTECTION DEVICE (EPD) WAS SUCCESSFULLY DEPLOYED DISTAL TO THE LESION; HOWEVER, DURING DELIVERY CATHETER REMOVAL, THE EPD WAS PULLED OUT IN THE OPEN POSITION WITH THE WIRE WRAPPED AROUND THE DELIVERY CATHETER. REPORTEDLY, THERE WAS TORQUING AND TURNING WHILE PLACING THE DEVICE AND IT WAS THOUGHT THAT THE TORQUING AND TURNING MAY HAVE CAUSED THE WIRE TO WRAP AROUND THE DELIVERY CATHETER. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 1030751

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR