BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1961839 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00319
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 23, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. OTHER: HEPARIN. EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (22438-19, LOT # 0101951). THE STENT REMAINS INSIDE THE PATIENT. TRANSIENT ISCHEMIC ATTACK (TIA) MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE DEVICE INSTRUCTIONS FOR USE, TIA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT THE DAY AFTER THE IMPLANTATION OF THE XACT STENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK WITH LEFT SIDED WEAKNESS AND ALTERED MENTAL STATUS. THE CT SCAN OF THE HEAD REVEALED NO ACUTE ABNORMALITY. THE EVENT RESOLVED THE SAME DAY WITHOUT INTERVENTION, BUT THE PATIENT WAS DISCHARGED THREE DAYS AFTER THE PROCEDURE. 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 0080361

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization