BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2143385 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04547
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 STROKE, VISUAL DISTURBANCES, HEADACHE AND WEAKNESS ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR REPORTED PATIENT ADVERSE EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE DAYS POST STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY THE PATIENT WAS RE-HOSPITALIZED WITH A STROKE. SYMPTOMS INCLUDED ACUTE ONSET LEFT SIDE VISUAL CHANGES, HEADACHE, LEFT FACIAL DROOP AND INCREASED WEAKNESS IN THE LEFT ARM. THERE WAS NO REPORTED TREATMENT GIVEN. THE PATIENT'S CONDITION IS CONTINUING BUT IMPROVED. 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 0111261

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| S