BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3250945 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04726
    Event Type
    Death
    Date Received
    July 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    July 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. THE REPORTED PATIENT EFFECTS OF BRADYCARDIA, EMBOLISM, AND DEATH ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM INSTRUCTIONS FOR USE (IFU). 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE RX ACCULINK REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, ADDITIONAL INFORMATION RECEIVED REPORTED THAT BRADYCARDIA BEGAN POST IMPLANTATION OF THE ACCULINK STENT. NO TREATMENT WAS GIVEN FOR THE IN-STENT THROMBUS NOTED POST IMPLANTATION OF THE ACCULINK. THE FILTER WHICH ONLY OPENED PARTIALLY DID NOT OPEN PROPERLY POSSIBLY BECAUSE OF THE PATIENT ANATOMY; HOWEVER, IT WAS NOT NOTICED UNTIL THE PATIENT DEATH HAPPENED AND WHILE REVIEWING THE CASE NEXT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MILDLY CALCIFIED, MILDLY TORTUOUS, PROXIMAL INTERNAL CAROTID ARTERY, AN EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE (EPD) WAS DEPLOYED FOLLOWED BY THE IMPLANTATION OF A 6-8 X 30 MM ACCULINK STENT. THE PATIENT EXPERIENCED BRADYCARDIA DURING THE PROCEDURE AND IT WAS NOTED VIA ANGIOGRAPHY THAT THE 6-8 X 30 MM ACCULINK STENT WAS FRACTURED AND STENT THROMBUS WAS PRESENT WHICH WAS NOT BEING FULLY CAPTURED BY THE EMBOSHIELD NAV6 EPD FILTER BECAUSE IT WAS NOTED TO HAVE NOT OPENED PROPERLY IN THE VESSEL. THE PATIENT EXPIRED 12 HOURS POST PROCEDURE. THE REPORTED CAUSE OF DEATH WAS DUE TO STENT FRACTURE RESULTING IN STENT THROMBOSIS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352580 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2080661

    Patients

    Seq Age Sex Outcome Treatment
    1 Death STENT: 6-8X30MM ACCULINK