BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1929574 · Received December 15, 2010

    Report

    Report Number
    3004742046-2010-00607
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. CONCOMITANT MEDICAL PRODUCTS: STENT: ACCULINK (1011343-40, LOT # 0092161); EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (22438-19, LOT # 0101251); OTHER: HEPARIN. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EMBOSHIELD NAV 6 WAS NOT RETURNED FOR INVESTIGATION WHICH MAY HAVE AIDED IN THE DETERMINATION OF THE CAUSE, HOWEVER, THE MIGRATION OF THE FILTER BASKET CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, DEVICE PLACEMENT TECHNIQUE, ACCESSORY DEVICE SUPPORT, AND INSUFFICIENT LANDING ZONE FOR THE FILTER BASKET. THE EMBOSHIELD NAV6 INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING PRECAUTIONS: OTHER INTERVENTIONAL DEVICES SHOULD NOT CONTACT THE FILTRATION ELEMENT. 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. THE TIP OF AN INTERVENTIONAL DEVICE SHOULD NOT CONTACT THE FILTRATION ELEMENT. FAILURE TO MAINTAIN ADEQUATE DISTANCE BETWEEN THE FILTRATION ELEMENT AND THE GUIDE WIRE STEP COULD RESULT IN INADVERTENT FILTRATION ELEMENT MOVEMENT AND INTERVENTIONAL DEVICE TIP / FILTRATION ELEMENT ENTANGLEMENT AND / OR FILTRATION ELEMENT / STENT ENTANGLEMENT IF GUIDE CATHETER OR SHEATH PROLAPSE OCCURS. DURING STENT PLACEMENT, 1.5 CM OF VESSEL SHOULD BE LEFT BETWEEN THE DISTAL MARGIN OF THE STENT AND THE FILTRATION ELEMENT. BASED ON THE CASE DESCRIPTION, THE FILTER MIGRATION APPEARS TO BE RELATED TO INADVERTENTLY PULLING THE FILTER BACK DURING RETRIEVAL AND THE REPORTED DIFFICULTY REMOVING APPEARS TO BE DUE TO THE FILTER BEING CAUGHT WITHIN THE STENT STRUTS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. OVERALL, THE REPORTED MIGRATION AND DIFFICULTY REMOVING APPEAR TO BE RELATED TO CASE CIRCUMSTANCES, AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT COMMON INTERNAL CAROTID BIFURCATION. THERE WAS NO ISSUE PLACING THE FILTER. AFTER SUCCESSFUL STENT DEPLOYMENT AND UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE NAV 6 FILTER ELEMENT WAS INADVERTENTLY PULLED DOWN TO MID STENT. AN ATTEMPT WAS MADE TO MOVE THE FILTER DISTAL WITH THE RECOVERY CATHETER, BUT IT WOULD NOT MOVE. THE FILTER WAS PULLED BACK INTO THE RECOVERY CATHETER, AND THOUGHT TO HAVE BEEN REMOVED, HOWEVER, AT SOME POINT DURING REMOVAL, THE FILTER CAME BACK OUT AND WAS NOT NOTICED. A NEW NAV 6 FILTER WAS ADVANCED, BUT STOPPED MID-WAY IN THE STENT AT WHICH TIME THE FIRST FILTER WAS OBSERVED AT THE SAME LOCATION. THE NEW FILTER WAS ABLE TO PUSH THE FIRST FILTER BACK TO IT'S REQUIRED POSITION DISTAL TO THE STENT AND THEN THE NEW FILTER WAS EASILY REMOVED. THE PROCEDURE CONTINUED WITH NO EFFECTS TO THE PATIENT. THE ORIGINAL FILTER WAS RECOVERED WITHOUT FURTHER ISSUE. THE PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-VS 0092951

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention