BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2008022 · Received March 4, 2011

    Report

    Report Number
    2024168-2011-01410
    Event Type
    Death
    Date Received
    March 4, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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. DAY OF BIRTH WAS NOT PROVIDED; ESTIMATED AS THE FIRST OF THE MONTH. DIL CATH: VIATRAC 5 X 20 MM, VENTURE CATHETER, FOX SV PTA BALLOON, HEADWAY 17, HEADHUNTER GUIDE WIRE: TERUMO WIRES. SHEATH: 9F 23 CM BRIGHT TIP; STENT: RX ACCULINK (PART 1010127-40, LOT 9062951); HEPARIN. THE RX ACCULINK IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: PROCEDURAL CINE IMAGES WERE REVIEWED BY THE ABBOTT VASCULAR. IT WAS OBSERVED THAT THE ANATOMY WAS CALCIFIC AND MILDLY TORTUOUS. THE IMAGES DEMONSTRATED THE EMBOSHIELD NAV6 DISTAL TO THE ACCULINK STENT AND DID NOT SHOW ANY INTERACTION BETWEEN THE TWO. ANALYSIS OF THE EMBOSHIELD NAV6 EPD NOTED BLOOD IN AND ON THE FILTRATION ELEMENT AND ON THE COILS AND CORE, CONSISTENT WITH HANDLING AND USE DURING THE PROCEDURE. ANALYSIS FURTHER NOTED A SEPARATION IN THE CORE AND 2 IN THE INTERMEDIATE COILS. THE SEPARATIONS ARE LIKELY FROM THE SURGEON CUTTING THROUGH THE DEVICE TO REMOVE IT FROM THE ANATOMY. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS CONFIRMED THAT THE SEPARATIONS ARE RELATED TO MECHANICAL DAMAGE AND TENSILE OVERLOAD. SEM ALSO NOTED CORROSION, BUT THIS WAS LIKELY DUE TO THE TRANSPORT OF THE WIRE DURING THE RETURN PROCESS AND WAS NOT RELATED TO THE PROCEDURE. TWO BENDS WERE OBSERVED IN THE CORE WHICH MAY HAVE ALSO BEEN RELATED TO THE SURGICAL REMOVAL. THE INTERMEDIATE COILS WERE OBSERVED TO BE STRETCHED AND THE TIP COILS WERE OFFSET, WHICH IS ALSO CONSISTENT WITH HANDLING RELATED TO SURGICAL REMOVAL. AS THERE WAS NOTHING REPORTED ABOUT THE BAREWIRE HAVING SEPARATIONS, BENDS, OR COIL ALIGNMENT ISSUES, IT IS LIKELY THAT ALL THESE OBSERVED MODES OF DAMAGE ARE DUE TO THE SURGICAL INTERVENTION AND WERE NOT RELATED TO THE REPORTED ENTANGLEMENT. IT WAS REPORTED THAT THE EMBOSHIELD NAV6 RETRIEVAL CATHETER (RC) WAS UNABLE TO ADVANCE PAST THE PROXIMAL EDGE OF THE STENT. THE INABILITY TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE PHYSICIAN REPORTED THAT IT FELT LIKE THE BAREWIRE MAY HAVE BECOME ENTANGLED WITH THE PROXIMAL EDGE OF THE STENT, THEREBY PREVENTING ANY DEVICE FROM ADVANCING PAST THE PROXIMAL EDGE OF THE STENT. IN THIS SITUATION, THERE WAS NO BUDDY WIRE SO THE GUIDE WIRE WOULD HAVE TO HAVE BEEN INSIDE THE CENTER OF THE STENT. THE ONLY POSSIBLE INTERACTION WOULD HAVE BEEN WITH THE CROWN OF THE SELF EXPANDING STENT. THE GUIDE WIRE INTERACTING WITH THE CROWN IS UNLIKELY AS THE SELF EXPANDING STENT (INCLUDING THE CROWN) WOULD TEND TO OPPOSE THE VESSEL WALL AND OFFER NO EDGE FOR THE GUIDE WIRE TO INTERACT WITH. THE RC WAS NOT RETURNED FOR ANALYSIS AND THE BAREWIRE WAS HEAVILY ALTERED IN THE SURGICAL REMOVAL FROM THE ANATOMY. ANALYSIS INDICATED THAT THE RX ACCULINK STENT WAS UNDAMAGED. IN REVIEW OF THIS INFORMATION AND THE CINE IMAGES PROVIDED, THERE IS NOT ENOUGH INFORMATION TO DEFINITIVELY SUGGEST THAT THE STENT AND GUIDE WIRE WERE, IN FACT, ENTANGLED AND A DEFINITIVE CAUSE COULD NOT BE DETERMINED. THERE WAS INDICATION THAT THE VESSEL WAS HEAVILY CALCIFIED AND NOTABLY TORTUOUS IN THE PROXIMAL AREA OF THE STENT. THESE ANATOMICAL ISSUES LIKELY LED TO THE FAILURE OF ADVANCING THE RC AND SUBSEQUENT DEVICES. IT WAS REPORTED THAT THE EMBOSHIELD NAV6 FILTER ENTANGLED WITH THE IMPLANTED RX ACCULINK STENT. IT APPEARS LIKELY THAT THIS HAPPENED DUE TO REPEATED MANIPULATIONS OF THE BAREWIRE WHICH SLOWLY MOVED THE FILTER PROXIMAL. THIS MAY HAVE HAPPENED WHILE ATTEMPTING TO ADVANCE THE EMBOSHIELD NAV6 RC. THIS ENTANGLEMENT WILL BE ATTRIBUTED TO INADVERTENT USER MISHANDLING DURING REPEATED GUIDE WIRE INTERACTIONS. STOKE, EMBOLISM, AND DEATH ARE LISTED AS POTENTIAL ADVERSE EFFECTS IN THE EMBOSHIELD NAV6 INSTRUCTIONS FOR USE (IFU). A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR ENTANGLEMENT WITH ANOTHER DEVICE OR DIFFICULT TO ADVANCE THE RECOVERY CATHETER FOR THIS LOT. IN MANUFACTURING, ALL RETRIEVAL CATHETERS ARE SUBJECTED TO A VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED ON A SAMPLE OF ALL EMBOLIC PROTECTION DEVICE PARTS TO VERIFY FUNCTIONALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT INTERNAL CAROTID ARTERY, THE EMBOSHIELD NAV6 FILTER WAS SUCCESSFULLY DEPLOYED DISTAL TO THE STENOTIC AREA. PREDILATATION WAS PERFORMED WITH A 5X20 VIATRAC CATHETER AND A RX ACCULINK STENT WAS DEPLOYED WITH THE DISTAL EDGE WELL PAST THE STENOTIC AREA AND PROXIMAL EDGE TO THE START OF THE TORTUOUS INTERNAL CAROTID ARTERY. AFTER STENT DEPLOYMENT, IN AN ATTEMPT TO RETRIEVE THE FILTER, THE RETRIEVAL CATHETER COULD NOT PASS THE PROXIMAL END OF THE STENT. SUBSEQUENTLY, THE FILTER WAS PULLED OPEN TO THE DISTAL EDGE OF THE STENT AND THE TWO DEVICES BECAME ATTACHED. THE RETRIEVAL CATHETER WAS REMOVED. A NUMBER OF DEVICES WERE USED IN AN UNSUCCESSFUL ATTEMPT TO PASS THROUGH THE PROXIMAL END OF THE STENT WHICH INCLUDED NON-ABBOTT CATHETERS, NON-ABBOTT GUIDE WIRES AND THE FOX SV PTA CATHETER. REPORTEDLY, THE PHYSICIAN FELT THAT THE NAV6 BAREWIRE GUIDE WIRE WAS STUCK IN THE PROXIMAL END OF THE STENT. THE PATIENT WAS TAKEN TO SURGERY AND THE NAV6 FILTER AND RX ACCULINK STENT WERE REMOVED. DURING THE SIX HOUR PROCEDURE, THE PATIENT'S BLOOD FLOW WAS GOOD. HOWEVER, POST PROCEDURE, THE PATIENT'S THROAT BEGAN TO SWELL AND HAD TROUBLE BREATHING. THE PATIENT WAS RESUSCITATED AND EMERGENCY TRACHEOTOMY WAS PERFORMED. THE PATIENT HAD AN EMBOLISM AND A LARGE BILATERAL STROKE WITH ANOXIC BRAIN DAMAGE. THE PATIENT WAS IN THE STROKE UNIT WITH NO CORNEAL, VERBAL. OR FLEXOR RESPONSE TO PAIN. THE PATIENT EXPIRED SIX DAYS POST PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN 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 9060251

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death