BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2210059 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05696
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 STROKE AND WEAKNESS ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE PRODUCT 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 THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT (CVA) AFTER THE CAROTID STENTING PROCEDURE. ALTHOUGH THE COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO ACUTE HEMORRHAGE, THE NEUROLOGIST FELT THE PATIENT HAD A SMALL CVA. NO TREATMENT WAS PROVIDED. THE PATIENT HAD RESIDUAL HAND WEAKNESS AT DISCHARGE THE NEXT DAY. 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 1042161

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability EMBOLIC PROTECTION: EMBOSHIELD NAV 6