BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2072265 · Received April 28, 2011

    Report

    Report Number
    2024168-2011-02984
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 NAUSEA AND TRANSIENT ISCHEMIC ATTACK ARE LISTED IN THE XACT INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS. 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 A XACT STENT WAS SUCCESSFULLY IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY. INTERVENTION WAS PLANNED FOR THE LEFT CAROTID ARTERY THE FOLLOWING MONTH FOR TREATMENT OF 70% STENOSIS. THE PATIENT WAS DISCHARGED AND ON THE WAY HOME EXPERIENCED APHASIA AND NAUSEA. THE PATIENT WAS READMITTED TO THE HOSPITAL AND WAS TREATED WITH HEPARIN. THE SYMPTOMS, DIAGNOSED AS TRANSIENT ISCHEMIC ATTACK, RESOLVED WITHIN 24 HOURS. THOUGH REQUESTED, 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 78 YR Hospitalization| R