BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2244043 · Received September 12, 2011

    Report

    Report Number
    2024168-2011-06250
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF STROKE AND EMBOLISM ARE KNOWN POTENTIAL ADVERSE EVENTS AS LISTED IN THE NAV6 INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR REPORTED PATIENT ADVERSE EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT DURING THE ACCULINK STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY DUE TO DISTAL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY. THE PATIENT WAS TREATED WITH MEDICATION AND ATTEMPTED MECHANICAL EMBOLECTOMY. AFTER THE PROCEDURE THE PATIENT REMAINED INTUBATED IN THE INTENSIVE CARE UNIT FOR 1 DAY. HEAD CT WAS NEGATIVE FOR INFARCTION. CAROTID DOPPLER SHOWED GOOD FLOW THROUGHOUT AND A PATENT STENT. THE PATIENT RETURNED TO NEUROLOGICAL BASELINE 2 DAYS AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS 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 0092151

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R| S STENT: RX ACCULINK