BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2003289 · Received February 28, 2011

    Report

    Report Number
    2024168-2011-01255
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CEREBROVASCULAR ACCIDENT, (STROKE OR OTHER NEUROLOGICAL COMPLICATIONS), EMBOLISM AND WEAKNESS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE EMBOSHIELD NAV6 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

    IT WAS REPORTED VIA A TRIAL THAT ONE DAY POST RIGHT INTERAL CAROTID ARTERY STENTING PROCEDURE WITH XACT STENT, THE PATIENT EXPERIENCED LOWER EXTREMITY WEAKNESS WHICH WAS DIAGNOSED AS A STROKE. MRI RESULTS SHOW NUMEROUS PUNCTATE ACUTE INFARCTS INVOLVING MULTIPLE VASCULAR DESCRIPTIONS BILATERALLY SUGGESTING POSSIBLE EMBOLIC ETIOLOGY, WHICH THE PHYSICIAN FEELS OCCURRED DURING THE PROCEDURE. TREATMENT INCLUDED CONTINUATION OF ASPIRIN AND PLAVIX. THE PATIENT'S CONDITION IS CONTINUING BUT IMPROVED. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY TWO DAYS AFTER THE PROCEDURE. THOUGH 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 0102851

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| S HEPARINXACT STENT