BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1984310 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00804
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 17, 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 HYPOTENSION AND VISUAL DISTURBANCES ARE LISTED IN THE PRODUCT INSTRUCTION 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 VIA A STUDY THAT POST XACT STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED RIGHT EYE AMAUROSIS FUGAX WHEN HER BLOOD PRESSURE DROPPED BELOW 140 SYSTOLIC. NEOSYNEPHRINE WAS GIVEN AND WHEN BLOOD PRESSURE REACHED GREATER THAN 140 SYSTOLIC, THE CONDITION RESOLVED. THE PATIENT WAS DISCHARGED HOME TWO DAYS AFTER THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, 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 0082061

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R BIVALIRUDINEMBOLIC PROTECTION: EMBOSHIELD NAV 6