BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2080111 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03237
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WAS PERFORMED ON THE SURFACES OF THE SEPARATION. THE RESULTS SUGGEST THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD AND THE COIL FAILURE MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD. THIS IS CONSISTENT WITH THE CORE OF THE WIRE BEING EXPOSED TO FORCES BEYOND THE MATERIAL LIMITATIONS APPLIED THROUGH PULLING, TORQUING AND/OR TWISTING OF THE PROXIMAL END OF THE WIRE AGAINST RESISTANCE, WHICH IN THIS CASE, MAY BE DUE TO THE INTERACTION BETWEEN THE FILTER AND THE RETRIEVAL CATHETER. THE ADDITIONAL KINKS AND BENDS NOTED ON THE WIRE WERE POSSIBLY INDUCED DURING THE DIFFICULTY RETRIEVING AND SUBSEQUENT SEPARATION OF THE BAREWIRE. DIFFICULTY IN RETRIEVING THE FILTRATION ELEMENT MAY INCLUDE, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, NEWLY DEPLOYED STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL, FILTRATION ELEMENT FULL OF DEBRIS PREVENTING THE FILTER FROM COLLAPSING OR DAMAGE TO THE RETRIEVAL CATHETER. IN THIS CASE, THE RETRIEVAL CATHETER WAS NOT RETURNED FOR ANALYSIS; HOWEVER, BASED ON THE REPORTED INFORMATION AND ANALYSIS OF THE RETURNED DEVICE, IT MAY BE POSSIBLE THAT AS THE RETRIEVAL CATHETER WAS ADVANCED UP TO THE FILTER LEVEL, THE FILTRATION ELEMENT WAS UNABLE TO COLLAPSE IN THE RETRIEVAL CATHETER. ADDITIONALLY, IT MAY BE POSSIBLE THAT FORCE WAS APPLIED BY PULLING THE WIRE DURING THE ATTEMPT TO COLLAPSE THE FILTER CAUSING THE CORE TO SEPARATE PROXIMAL TO THE STEP. ADDITIONALLY, WITH CONTINUED PULLING, THE COILS MAY HAVE BECOME STRETCHED AS NOTED. IT IS ALSO POSSIBLE THAT THE FILTRATION ELEMENT REMAINED ON THE STRETCHED PORTION OF THE TIP COILS ALLOWING THE ABILITY TO GENTLY PULL THE FILTER INTO THE ANATOMY, WHERE IT WAS ULTIMATELY RETRIEVED WITH THE MICRO-SNARE. OVERALL, A CONCLUSIVE CAUSE FOR THE DIFFICULTY RETRIEVING THE FILTER AND SUBSEQUENT DAMAGE TO THE BAREWIRE COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE RETURNED EMBOLIC PROTECTION SYSTEM (EPS) NOTED BLOOD ON THE FILTRATION ELEMENT, ON THE BAREWIRE CORE, COILS AND ON THE DELIVERY CATHETER SHAFT, CONSISTENT WITH THE REPORTED USE. THERE WAS SALINE ON THE DELIVERY CATHETER GUIDE WIRE EXIT PORT. ONLY THE FILTRATION ELEMENT, BAREWIRE, DELIVERY CATHETER AND THREE NON-ABBOTT GUIDING CATHETERS WERE RETURNED. THE REPORTED SEPARATION WAS CONFIRMED. THE BAREWIRE CORE AND COILS WERE SEPARATED PROXIMAL TO THE DISTAL END STOP FOR THE FILTRATION ELEMENT. THE BARE WIRE COILS WERE COMPLETELY STRETCHED PROXIMAL TO THE SEPARATION AS REPORTED. THERE WERE THREE KINKS IN THE CORE PROXIMAL TO THE SEPARATION. THERE WAS A BEND IN THE TIP PROXIMAL TO THE TIP BALL. THERE WAS NO OTHER DAMAGE NOTED TO THE BAREWIRE. THERE WAS NO DAMAGE NOTED TO THE FILTRATION ELEMENT, DELIVERY CATHETER, OR THE THREE NON-ABBOTT GUIDING CATHETERS. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WAS PERFORMED ON THE SURFACES OF THE SEPARATION. THE RESULTS SUGGEST THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD AND THE COIL FAILURE MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD. THIS IS CONSISTENT WITH THE TIP OF THE WIRE BEING EXPOSED TO FORCES BEYOND THE MATERIAL LIMITATIONS APPLIED THROUGH TORQUING AND/OR TWISTING OF THE PROXIMAL END OF THE WIRE WITH THE TIP OF THE WIRE BEING TRAPPED, LIKELY WITHIN THE NEWLY PLACED STENT. THE ADDITIONAL KINKS AND BENDS NOTED ON THE WIRE WERE LIKELY INDUCED DURING THE ATTEMPTS TO FREE THE TIP OF THE WIRE. DIFFICULTY RETRIEVING THE FILTRATION ELEMENT THROUGH THE STENT MAY INCLUDE, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, NEWLY DEPLOYED STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL, LACK OF GUIDE CATHETER SUPPORT OR INTERACTION BETWEEN ASSOCIATED DEVICES. IT MAY BE POSSIBLE THAT THE DIFFICULTY ADVANCING THE RETRIEVAL CATHETER IS DUE TO INTERACTION WITH NEWLY PLACED STENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS FOR CORE DETACHMENT OR STRETCHED COILS REPORTED FOR THIS LOT. OVERALL, THE DAMAGE TO THE BAREWIRE APPEARS TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY. 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 VIA A TRIAL THAT DURING A CAROTID STENTING PROCEDURE THE NAV6 FILTER WAS ADVANCED AND DEPLOYED WITHOUT ISSUE; STENTING WITH AN ABBOTT STENT WAS UNEVENTFUL. DURING FILTER RETRIEVAL, THE RECOVERY CATHETER (RC) COULD NOT BE ADVANCED TO RETRIEVE THE FILTER; THEY KEPT PUSHING IT AT THE HUB BUT IT WOULD NOT ADVANCE FAR ENOUGH IN THE VESSEL TO RETRIEVE THE FILTER. THE PHYSICIAN HAD TO INTENTIONALLY PULL THE OPEN THROUGH THE NEWLY DEPLOYED STENT INTO THE AORTA. IT WAS NOTED THAT IN THE AORTA AREA, THE BAREWIRE HAD FRAYED, UNRAVELED AND SEPARATED AT THE DISTAL 3 CM STEP AND A SNARE DEVICE WAS USED TO RETRIEVE THE DETACHED WIRE FRAGMENT AND THE FILTER ELEMENT. THE PATIENT WAS ASYMPTOMATIC AND THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED (B)(6) 2011 TO HOME. ADDITIONAL INFORMATION RECEIVED VIA SOURCE DOCUMENTS FROM THE ACCOUNT STATES, "SURPRISINGLY, WHEN WE TRIED TO RETRIEVE THE FILTER THERE, EVEN THOUGH WE ARE UP TO THE FILTER LEVEL THERE WE WERE NOT ABLE TO RETRIEVE IT AND WE REALIZED THAT THE WIRE MAY HAVE FRACTURED THERE AT THAT POINT. 'THIS APPEARS TO BE PROBABLY MANUFACTURING DEFECT.' SO THE FILTER WAS GENTLY PULLED BACK. EVEN WITH A FRACTURED WIRE WE WERE ABLE TO PULL IT BACK INTO THE DISTAL ABDOMINAL AORTA VERY GENTLY AND VERY CAREFULLY AND THEN IT WAS RETRIEVED WITH A 10X10MM GOOSENECK MICRO-SNARE OF 4 FR SYSTEM AND REMOVED. IT WAS NOTED IN FACT, IT APPEARS THAT THE WIRE HAS A SIGNIFICANT MULTIPLE UNCOILING OF THE WIRES, AND THE FILTER WIRE ALSO HAS BROKEN OFF AT A SEPARATE PIECE WHICH WAS RETRIEVED WITHOUT ANY COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE WELL. NEUROVASCULAR STATUS REMAINED STABLE." NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 1011051

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention RX ACCULINK STENT, BIVALIRUDIN,