BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2143452 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04550
    Event Type
    Death
    Date Received
    June 29, 2011
    Date of Event
    October 19, 2010
    Report Date
    June 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, HEMORRHAGE AND DEATH ARE KNOWN 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, SEVERAL HOURS AFTER THE IMPLANTATION OF THE XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A LEFT FRONTAL INTRACEREBRAL HEMORRHAGE. THE PATIENT UNDERWENT A LEFT FRONTAL LOBOTOMY. THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY ON OR ABOUT (B)(6) 2010. ON AN UNKNOWN DATE, THE PATIENT EXPIRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH FILED, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT EXPIRED AT A NURSING FACILITY ON (B)(6) 2011. THE DEVICE LOT NUMBER WAS ALSO RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0072261

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death