BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2182632 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05349
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. FACTORS THAT MAY CONTRIBUTE TO A FRACTURED STENT INCLUDE, BUT ARE NOT LIMITED TO, DAMAGED STRUTS, LOW RADIAL FORCE, STRETCHED STENT, FATIGUE, OR INTERACTION WITH OTHER DEVICES. BASED ON THE XACT INSTRUCTIONS FOR USE, STENT FRACTURE, DEFORMATION AND/OR STENT DAMAGE ARE KNOWN POTENTIAL ADVERSE OUTCOMES ASSOCIATED WITH CAROTID STENTS. IN THIS CASE, NO ANOMALIES TO THE CATHETER WERE REPORTED DURING INSPECTION PRIOR TO USE. IN ADDITION, THERE WERE NO STENT RELATED DISCREPANCIES REPORTED AT THE TIME OF DEVICE PREPARATION AND INITIAL STENT IMPLANTATION. DURING MANUFACTURING, THE XACT STENT IS 100% VISUALLY INSPECTED UNDER MAGNIFICATION. THE STENTS ARE CHECKED FOR CONCENTRICITY, UNIFORMITY, PATTERN, AND SURFACE FINISH. THE STENTS ARE ALSO CHECKED FOR DEFECTS SUCH AS CRACKS, PITTING AND POOR ELECTRO POLISHING. THE XACT STENT DESIGN IS CAPABLE OF WITHSTANDING EXTREME REPEATED LOADING CONDITIONS WITHOUT EXPERIENCING STRUT CRACKING, BREAKAGES, OR DEFORMATION PER TESTING BASED ON WORST CASE CONDITIONS. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE OR ANY PRODUCT DEFICIENCY BASED ON THE REPORTED INFORMATION. ALTHOUGH, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED, BASED ON THE AVAILABLE INFORMATION, THE EVENT DOES NOT APPEAR TO BE RELATED TO A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE (B)(6) FOLLOW-UP POST XACT STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY, THE STENT WAS FOUND TO HAVE A GRADE 1 SINGLE STRUT FRACTURE. THE PATIENT DID NOT REPORT ANY ADVERSE EVENTS PRIOR TO THE FINDING AND HAS NOT EXPERIENCED ANY ADVERSE SEQUELA RELATED TO THE STENT FRACTURE. THERE WAS NO TREATMENT PROVIDED. 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 240456G

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR