BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2052211 · Received April 12, 2011

    Report

    Report Number
    2024168-2011-02571
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. HYPOTENSION MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, HYPOTENSION 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. BASED ON THE AVAILABLE INFORMATION, 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 THAT DURING THE STENTING PROCEDURE IN THE HEAVILY CALCIFIED RIGHT INTERNAL COMMON CAROTID ARTERY, THE PATIENT EXPERIENCED SEVERE HYPOTENSION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT AT THE COMPLETION OF THE PROCEDURE. CONCOMITANT HYPERTENSIVE MEDICATIONS WERE HELD AND DOPAMINE WAS GIVEN. THE CONDITION WAS DESCRIBED AS IMPROVED BUT CONTINUING AND THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE. NO ADDITIONAL ADVERSE PATIENT SEQUELA WAS REPORTED. 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 0121061

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R EMBOLIC PROTECTION: EMBOSHIELD NAV6HEPARIN