BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1963158 · Received January 18, 2011

    Report

    Report Number
    2024168-2011-00372
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. TRANSIENT ISCHEMIC ATTACK (TIA) AND AIR EMBOLISM MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, AND ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. INFORMATION AVAILABLE IN THE CASE DESCRIPTION IS NOT SUFFICIENT TO DETERMINE A RELATIONSHIP BETWEEN THE EVENT AND THE ABBOTT VASCULAR PRODUCT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECTS 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 DURING THE XACT STENT IMPLANTATION, AFTER THE STENT WAS PLACED IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK WITH LEFT HEMIPARESIS WHICH THE PHYSICIAN THOUGHT MAY HAVE BEEN CAUSED BY A SMALL AIR EMBOLISM. SYMPTOMS RESOLVED WITHIN A FEW HOURS. THERE WAS NO REPORTED TREATMENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 0081661

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other HEPARIN, EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE