BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2232017 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06104
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF AIR EMBOLISM AND NEUROLOGICAL DEFICIT/DYSFUNCTION ARE LISTED IN THE EMBOSHIELD NAV 6 INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE XACT STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY, AFTER THE EMBOSHIELD NAV6 WAS INSERTED, THE PATIENT BECAME DISORIENTED FOR 30-45 SECONDS AND REGAINED NORMAL MENTATION. THE PHYSICIAN NOTED SEVERAL AIR BUBBLES HAD CROSSED TO THE LEFT CAROTID ARTERIAL SYSTEM. CT OF THE HEAD/NECK POST PROCEDURE SHOWED NORMAL RESULTS. ADDITIONALLY, POST PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION WHICH WAS TREATED WITH INTRAVENOUS FLUIDS AND A DOPAMINE INFUSION. THE HYPOTENSION RESOLVED THE FOLLOWING DAY AND THE PATIENT WAS DISCHARGED HOME. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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 1061461

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention OTHER: BIVALIRUDINSTENT: XACT