BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2212306 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05753
    Event Type
    Death
    Date Received
    August 15, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 HEMORRHAGE, DEATH, VISUAL DISTURBANCES AND WEAKNESS ARE KNOWN OBSERVED AND 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 A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 50 MINUTES POST XACT STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY (RICA), THE PATIENT EXPERIENCED LEFT UPPER AND LOWER EXTREMITY WEAKNESS AND RIGHT EYE BLINDNESS, WITH A SLIGHTLY DILATED RIGHT PUPIL. PER CT SCAN, AN ACUTE PARENCHYMAL HEMORRHAGE WAS SEEN ON THE RIGHT SIDE AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. MEDICATIONS WERE PROVIDED; HOWEVER, THE CONDITION WORSENED AND ON (B)(6) 2011, THE PATIENT DIED. 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 1051861

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death EMBOLIC PROTECTION: EMBOSHIELD NAV6, BIVALIRUDIN.