BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 4792408 · Received May 22, 2015

    Report

    Report Number
    2024168-2015-02927
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED DIFFICULTY REMOVING WAS NOT ABLE TO BE CONFIRMED BECAUSE THE RETRIEVAL CATHETER WAS NOT RETURNED. BASED ON A VISUAL INSPECTION 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. 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 EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL ISSUE/OBSERVATION CAUSED BY OR RELATED TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE NARROW, ECCENTRIC, INTERNAL CAROTID ARTERY, AFTER THE 8 FR SHEATH AND GUIDE CATHETER WERE POSITIONED, THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE (EPD) WAS USED AND AN UNSPECIFIED STENT WAS IMPLANTED WITHOUT ISSUE. IT WAS NOTED THAT WHEN ATTEMPTING TO RETRIEVE THE NAV6 WITH THE RETRIEVAL CATHETER, RESISTANCE WAS MET AND THE EPD WAS ONLY PARTIALLY CAPTURED. AN ANGIOGRAPHIC CATHETER WAS USED TO SUCCESSFULLY RETRIEVE AND REMOVE THE EPD FROM THE VESSEL WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336727 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 4120161

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8F SHEATH