BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1961737 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00305
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    April 9, 2010
    Report Date
    December 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    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. EMBOLIC PROTECTION: EMBOSHIELD NAV 6 ((B)(4), LOT # 0022551) THE STENT REMAINS INSIDE THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. NON-STROKE NEUROLOGICAL DEFICIT IS LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU) AS A KNOWN POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER THE IMPLANTATION OF THE XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT WITH APHASIA, FATIGUE, AND DISORIENTATION TO DATE AND TIME. THE CT SCAN OF THE HEAD SHOWED NO NEW INFARCTION. THERE WAS NO REPORTED INTERVENTION. THE PATIENT'S CONDITION RESOLVED FOUR DAYS AFTER THE ONSET OF SYMPTOMS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 9101951

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O