BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3029121 · Received April 1, 2013

    Report

    Report Number
    2024168-2013-01866
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    September 24, 2012
    Report Date
    March 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. ESTIMATED DATE. ARTICLE - OPTICAL COHERENCE TOMOGRAPHY IMAGING IN ASYMPTOMATIC PATIENTS WITH CAROTID ARTERY STENOSIS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF EMBOLISM AND TRANSIENT ISCHEMIC ATTACK (TIA) ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM ELECTRONIC INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW: MEHMET CILINGIROGLU, ABDUL HAKEEM, MARC FELDMAN, MARK WHOLEY.(CARDIOVASCULAR REVASCULARIZATION MEDICINE 14 (2013) 53-56): OPTICAL COHERENCE TOMOGRAPHY IMAGING IN ASYMPTOMATIC PATIENTS WITH CAROTID ARTERY STENOSIS. INTRAVASCULAR OPTICAL COHERENCE TOMOGRAPHY (IVOCT) RECENTLY EMERGED AS A NOVEL IMAGING MODALITY WITH A UNIQUE RESOLUTION TO IDENTIFY VULNERABLE PLAQUE CHARACTERISTICS. IN ONE CASE, DURING THE PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY FOR TREATMENT OF HIGH GRADE STENOSIS AND INTRALUMINAL THROMBOSIS, A 6MM EMBOSHIELD NAV 6 EMBOLIC PROTECTION FILTER WAS PLACED. ANGIOPLASTY AND STENTING WERE PERFORMED. FOLLOWING POST-DILATATION USING AN UNSPECIFIED 5X20 BALLOON, THE PATIENT DEVELOPED A TRANSIENT EPISODE OF WORD SEARCHING THAT RESOLVED FOLLOWING REMOVAL OF THE EMBOSHIELD FILTER. UPON REMOVAL OF THE FILTER, A TINY EMBOLIC FRAGMENT WAS NOTED AT THE FILTER TIP. THE PATIENT REMAINED IN THE HOSPITAL FOR ONE DAY WITH NORMAL NEUROLOGICAL FINDINGS AND WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133300 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other