BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2170734 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05062
    Event Type
    Death
    Date Received
    July 21, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 FEVER, SEPSIS AND DEATH ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS. THE ETO STERILIZATION RECORDS FOR THIS LOT WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL RECORDS OR ANOMALIES NOTED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE 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 9 DAYS POST XACT STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY, THE (B)(6) OLD PATIENT WAS REHOSPITALIZED WITH FEVER AND MALAISE. TESTS WERE RUN AND AGGRESSIVE ANTIBIOTICS THERAPY GIVEN. PATIENT WAS DIAGNOSED WITH ENDOCARDITIS. REPORTEDLY, THERE WAS NO OBVIOUS SOURCE OF SEPSIS, NO STENT ABNORMALITIES. ON (B)(6) 2011, THE PATIENT DIED. CAUSE OF DEATH WAS SEPSIS. ALTHOUGH REQUESTED, 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 1011961

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death