BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2192661 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05528
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ESTIMATED DATE OF THE EVENT WAS REPORTED AS OCCURRING THE WEEK OF (B)(6) 2011. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF TRANSIENT ISCHEMIC ATTACK, VISUAL DISTURBANCES AND EMBOLISM ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE 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

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: PATIENT WAS INSTRUCTED TO CONTINUE PLAVIX AND FOLLOW-UP WITH THE OPHTHALMOLOGIST IN 3 MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 4 WEEKS AFTER UNEVENTFUL STENTING OF THE MILDLY CALCIFIED RIGHT INTERNAL CAROTID ARTERY WITH AN XACT STENT, THE PATIENT EXPERIENCED A RIGHT VISUAL DISTURBANCE. THE EPISODE RESOLVED WITHIN TWO HOURS. THERE WAS NO TREATMENT. SUBSEQUENT OPHTHALMIC EXAM REVEALED THAT THERE WERE PARTICLES IN THE VESSEL BEHIND THE RIGHT EYE. EMBOLIC PHENOMENA CANNOT BE RULED OUT AS AN EXPLANATION FOR THESE PARTICLES. THE PATIENT HAD AN ULTRASOUND, BUT RESULTS ARE NOT AVAILABLE AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0121061

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other