BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1831821 · Received September 8, 2010

    Report

    Report Number
    3004742046-2010-00407
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED WHICH COULD HAVE AIDED IN THE DETERMINATION OF THE CAUSE, HOWEVER, THE MIGRATION OF FILTRATION ELEMENT 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 INSTRUCTIONS FOR USE (IFU) STATE THAT, PROPER GUIDING CATHETER/SHEATH SUPPORT SHOULD BE MAINTAINED IN THE COMMON CAROTID ARTERY THROUGHOUT THE PROCEDURE. THE IFU FURTHER STATES THAT THERE SHOULD BE 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 ENTANGLEMENT BETWEEN THE FILTRATION ELEMENT AND OTHER DEVICES. 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 FILTRATION ELEMENT ENGAGEMENT WITH THE CAROTID STENT SYSTEM/INTERVENTIONAL DEVICE TIP AND/OR FILTRATION ELEMENT ENTANGLEMENT WITH THE DEPLOYED STENT IF GUIDE CATHETER OR SHEATH PROLAPSE OCCURS. BASED ON AVAILABLE INFORMATION AND THE ABSENCE OF THE DEVICE FOR ANALYSIS, A CONCLUSIVE CAUSE APPEARS TO BE RELATED TO CIRCUMSTANCES DURING THE PROCEDURE AND NOT A MANUFACTURING RELATED DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE FINAL POST DILATATION OF THE XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY, THE NAV6 WAS INADVERTENTLY PULLED DOWN THROUGH THE XACT STENT BY THE PHYSICIAN. THE NAV6 WAS REMOVED FROM THE PATIENT AND A SECOND NAV6 WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA AFTER THE PROCEDURE REQUIRING TREATMENT WITH ATROPINE AND VASOPRESSORS FOR ONE DAY. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0061551

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HEPARIN