BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2193394 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05560
    Event Type
    Death
    Date Received
    August 5, 2011
    Date of Event
    June 25, 2011
    Report Date
    July 13, 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 DEATH, FEVER, HEMORRHAGE, NEUROLOGICAL EVENT AND SEPSIS ARE KNOWN POTENTIAL ADVERSE EVENTS AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED ADVERSE PATIENT EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT 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 UNEVENTFUL XACT STENTING PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT WAS HOSPITALIZED WITH ALTERED MENTAL STATUS, HIGH BLOOD SUGARS AND FEVERS. THE PATIENT WAS DIAGNOSED WITH SEPSIS/BACTEREMIA. CT OF THE HEAD REVEALED INTRACRANIAL HEMORRHAGE TO THE LEFT TEMPORAL AREA. THE FAMILY REQUESTED NO HEROIC MEASURES OR LIFE SUPPORT. THE PATIENT WAS GIVEN COMFORT CARE AND DIED ON (B)(6) 2011. 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 1011761

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H