BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2070014 · Received April 26, 2011

    Report

    Report Number
    2024168-2011-02947
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EFFECTS OF SEIZURE AND TREATMENT WITH MEDICATION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PRODUCT INSTRUCTION FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN XACT STENT WAS SUCCESSFULLY IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY. ONE DAY POST PROCEDURE, THE PATIENT EXPERIENCED A FOCAL SEIZURE. VERSED WAS ADMINISTERED. THE PATIENT WAS DISCHARGED TO HOME 4 DAYS POST PROCEDURE. 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 9061551

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R