BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2132811 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04312
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE SECOND EMBOSHIELD NAV 6 IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. MIGRATION OF THE FILTER 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 PROVIDES THE FOLLOWING PRECAUTIONS: 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. BASED ON THE REPORTED INFORMATION, THE FILTER MIGRATION APPEARS TO BE RELATED TO LOSS OF SHEATH SUPPORT DURING ADVANCEMENT OF THE ACCULINK CAUSING THE FILTRATION ELEMENT TO PULL BACK INTO THE LESION. THE DIFFICULTIES ADVANCING ALL DEVICES WERE REPORTED TO BE RELATED TO THE LESION CHARACTERISTICS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS FOR THIS LOT. A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. IN THIS CASE, THE REPORTED MIGRATION AND RESISTANCE APPEARS TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY (LICA) STENTING PROCEDURE THE LEFT COMMON CAROTID ARTERY (LCCA) WAS AT A 90 DEGREE ANGLE FROM THE INNOMINATE ARTERY, MAKING IT DIFFICULT TO ACCESS THE MODERATELY CALCIFIED LESION. AN EMBOSHIELD NAV 6 EMBOLIC PROTECTION DEVICE (EPD) WAS PLACED DISTAL TO THE LESION. THE LESION WAS SUCCESSFULLY PREDILATED WITH A VIATRAC 4.0X15MM BALLOON. WHEN ADVANCING A XACT STENT 8X6/40 TOWARD THE LESION, THE SHEATH WAS PULLED BACK PULLING THE EPD INTO THE LESION. THE 8X6/40 STENT WAS REMOVED AND THE EPD WAS RETRIEVED AND REMOVED, WITHOUT ISSUE. A SECOND EPD WAS PLACED. NEXT AN 8X6/30 XACT STENT WAS ATTEMPTED TO BE PLACED. THIS TIME, THE EPD WAS PULLED FROM ITS PARKING PLACE INTO THE LCCA. DUE TO THE MULTIPLE ANGLES OF THE LCCA, THERE WERE LONG DELAYS IN THE PROCEDURE AS IT WAS DIFFICULT ADVANCING THE DEVICES THROUGH THE ANGLES. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. ON (B)(6) 2011, AN ENDARTERECTOMY WAS PERFORMED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 1031651

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention XACT STENT 8X6/40