BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2143434 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04554
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 EFFECT OF TRANSIENT ISCHEMIC ATTACK (TIA) IS A KNOWN POTENTIAL ADVERSE EVENT AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT 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 DURING A LEFT INTERNAL CAROTID ARTERY (LICA) STENTING PROCEDURE, PRIOR TO THE DEPLOYMENT OF THE EMBOLIC PROTECTION DEVICE, THROMBUS WAS NOTED TO BE PRESENT. DURING THE PROCEDURE, THE PATIENT EXPERIENCED 2 MINUTES OF TRANSIENT RIGHT SIDED HEMIPARESIS AND EXPRESSIVE APHASIA WHICH WAS CAUSED BY A FULL FILTER. THE FILTER WAS ASPIRATED WITH A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, 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 1012051

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention STENT: XACT 8-6X40, BIVALIRUDIN.