BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2853560 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07622
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE TORN FILTER WAS ABLE TO BE CONFIRMED. THE DIFFICULTIES REMOVING THE FILTER AND FILTER MIGRATION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: IF THE FILTRATION ELEMT MOVES INTO THE STENTED SEGMENT PRIOR TO RETRIEVAL, DO NOT RETRIEVE WITHIN THE STENT. ADVANCE THE RX RETRIEVAL CATHETER SO THAT ITS TIP OPPOSES THE PROXIMAL PORTION OF THE FILTRATION ELEMENT AND GENTLY PUSH THE FILTRATION ELEMENT DISTALLY UNTIL IT IS SITUATED IN AN UNSTENTED PORTION OF THE VESSEL. ADDITIONALLY, THE IFU STATES: IF SIGNIFICANT RESISTANCE IS FELT, RETRACT THE GUIDE CATHETER OR SHEATH AND THE RX RETRIEVAL CATHETER TOGETHER. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE XACT STENT WAS ROUTINELY POST DILATED WITH A VIATEC BDC. THE EMBOSHIELD NAV 6 FILTER WAS CAPTURED AND WITH REMOVAL THE FILTER CAUGHT ON THE DISTAL END OF THE IMPLANTED XACT STENT. THE PHYSICIAN WAS ABLE TO MANIPULATE THE FILTER OFF OF THE DISTAL END OF THE IMPLANTED XACT STENT AND BRING THE FILTER DOWN FURTHER, BUT THE FILTER CAUGHT ON THE PROXIMAL END OF THE IMPLANTED XACT STENT. THE PHYSICIAN NEEDED TO TUG TO GET THE EMBOSHIELD NAV 6 FILTER OFF OF THE PROXIMAL END OF THE STENT AND REMOVED THE EMBOSHIELD NAV 6 FILTER SUCCESSFULLY. UPON REMOVAL THE EMBOSHIELD NAV 6 FILTER WAS FOUND TORN. NOTHING MORE WAS DONE AND THE PROCEDURE WAS COMPLETE. REPORTEDLY, BY LOOKING AT THE PICTURES, THE DISTAL PART OF THE IMPLANTED XACT STENT DOES NOT APPEAR TO BE FULLY APPOSED TO THE VESSEL WALL. THE NEXT DAY THE PATIENT EXPERIENCED ALTERED MENTAL STATUS AND A MAGNETIC RESONANCE IMAGING (MRI) WAS DONE WITH FINDINGS OF MULTIPLE INFARCTIONS CONSISTENT WITH A STROKE. THE SYMPTOMS ARE IMPROVING, BUT THE PATIENT IS STILL UNABLE TO AMBULATE OF HIS OWN. THERE WAS NO TREATMENT DONE AND ON (B)(6) 2012, THE PATIENT WAS DISCHARGED TO AN INPATIENT MEDICAL REHABILITATION CENTER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE EMBOSHIELD NAV6 AND THE XACT ARE BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBERS. (B)(4) - INCORRECT REMOVAL AND EXCESSIVE FORCE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEAVILY TORTUOUS, HEAVILY CALCIFIED, RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AN EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED WITHOUT PRE-DILATATION, TO THE DESIRED LOCATION PAST THE LESION. AN ACCULINK STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND AS THE ACCULINK ADVANCED THROUGH THE HEAVILY TORTUOUS ANATOMY, REPORTEDLY, IT PULLED THE EMBOSHIELD NAV 6 FILTER PROXIMALLY, CLOSER TO THE LESION. THE ACCULINK SDS WAS REMOVED AND THE EMBOSHIELD NAV 6 FILTER WAS REPOSITIONED DISTALLY. A VIATRAC BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO DILATE THE LESION AND THE SAME ACCULINK SDS WAS ADVANCED. AGAIN WITH ADVANCEMENT THE EMBOSHIELD NAV 6 FILTER WAS MOVED PROXIMALLY TOWARD THE LESION AND THE ACCULINK SDS WAS REMOVED. THE EMBOSHIELD NAV 6 FILTER WAS CAPTURED AND REMOVED. THE GUIDE WIRE WAS CHANGED TO A NEW LONG BARE WIRE AND ANOTHER SAME SIZE EMBOSHIELD NAV 6 EPS WAS ADVANCED AND SUCCESSFULLY PLACED. THE SAME ACCULINK SDS WAS RE-ADVANCED AND AGAIN THE NEW EMBOSHIELD NAV 6 FILTER WAS PULLED PROXIMALLY. A BUDDY WIRE TECHNIQUE WAS DONE WITH A NON-ABBOT GUIDE WIRE. THE SAME ACCULINK SDS WAS ADVANCED AND THE EMBOSHIELD NAV 6 FILTER WAS MOVED PROXIMALLY AGAIN. THE GUIDE WIRE WAS CHANGED TO AN ASAHI GRAND SLAM GUIDE WIRE AND THE SAME ACCULINK SDS WAS ADVANCED AND THE EMBOSHIELD NAV 6 FILTER WAS MOVED PROXIMALLY AGAIN. THE ACCULINK SDS WAS REMOVED AND A XACT (18 X 6 X 40 MM) SDS WAS ADVANCED AND SUCCESSFULLY IMPLANTED TO THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2072561

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR