BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3942260 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04595
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED FAILURE TO DEPLOY AND SEPARATION OF THE DELIVERY CATHETER WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED, MILDLY CALCIFIED LESION IN THE MILDLY TORTUOUS DISTAL INTERNAL CAROTID ARTERY. THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION; HOWEVER, IT FAILED TO DEPLOY AND THE DELIVERY SHEATH SEPARATED. THE SEPARATED SHEATH WAS SUCCESSFULLY RETRIEVED WITH THE GUIDING SHEATH. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS; HOWEVER, THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER EMBOSHIELD NAV 6 EPS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419231 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 4012961

    Patients

    Seq Age Sex Outcome Treatment
    1