BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1914162 · Received December 3, 2010

    Report

    Report Number
    3004742046-2010-00572
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS RETURNED WITH BLOOD IN THE POD AND ON THE TORQUE DEVICE, HANDLE, BAREWIRE, AND FILTRATION ELEMENT, CONSISTENT WITH BEING ADVANCED INTO THE ANATOMY AS REPORTED. THE FILTRATION ELEMENT WAS NOT RETURNED LOADED INTO THE DELIVERY CATHETER. THE RED CLIP WAS RETURNED ON THE HANDLE. THE TORQUE DEVICE WAS RETURNED TIGHT ON THE BAREWIRE, 30CM PROXIMAL TO THE SILVER MARKER. THE TEFLON WAS SCRAPED AT THE SAME LOCATION, INDICATING THAT THE TORQUE DEVICE MAY HAVE SLIPPED ON THE BAREWIRE FROM THE ORIGINAL POSITION ON THE SILVER MARKER. THERE WERE TWO BENDS IN THE CORE 1.5CM AND 7CM PROXIMAL TO THE TIP BALL. THERE WAS A KINK IN THE POD 6MM DISTAL TO THE MARKER BAND. THERE WAS NO OTHER DAMAGE NOTED TO THE EPS. THE TRAY WAS NOT RETURNED. BASED ON THE REPORTED INFORMATION AND ANALYSIS OF THE RETURNED PRODUCT, IT MAY BE POSSIBLE THAT THE FILTER PREMATURELY DEPLOYED DURING THE TIME THAT THE SYSTEM WAS WITHDRAWN. IT IS POSSIBLE THAT INTERACTION BETWEEN THE DELIVERY CATHETER AND SHUTTLE SHEATH ALONG WITH ADDITIONAL HANDLING CAUSED THE FILTER TO PREMATURELY DEPLOY. THERE WAS NO REPORTED DIFFICULTY DURING PREP, AND NO REPORT OF PREMATURE DEPLOYMENT PRIOR TO ADVANCING INTO THE ANATOMY, WHICH WOULD SUGGEST THAT THE FILTER DEPLOYED DURING USE. THE NOTED BENDS IN THE BAREWIRE AND KINK IN THE DELIVERY CATHETER POD LIKELY OCCURRED DURING USE AS THERE WAS NO DAMAGE REPORTED DURING THE PRIOR TO USE INSPECTION. THE DAMAGE MAY ALSO BE RELATED TO PACKAGING THE PRODUCT FOR RETURN TO ABBOTT VASCULAR. A CONCLUSIVE CAUSE FOR THE REPORTED PREMATURE DEPLOYMENT AND DAMAGE NOTED DURING THE ANALYSIS COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED THE REPORTED EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, IN THE MILDLY TORTUOUS LEFT INTERNAL CAROTID ARTERY, THE EMBOSHIELD NAV6 WAS ADVANCED UP THROUGH THE ARCH TO THE LESION WITHOUT RESISTANCE. THE PHYSICIAN WANTED TO RESHAPE THE BAREWIRE SO THE DEVICE WAS WITHDRAWN FROM THE ANATOMY. UPON REMOVAL, IT WAS NOTED THAT THE FILTER HAD PREMATURELY DEPLOYED FROM THE DILATATION CATHETER POD. IT IS NOT KNOWN WHEN THE FILTER PREMATURELY DEPLOYED; HOWEVER, THE FILTER WAS DEPLOYED WHEN REMOVED FROM THE ANATOMY. THE DEVICE WAS NO LONGER USED AND ANOTHER SAME-SIZED EMBOSHIELD NAV6 WAS USED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA 0072051

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR