BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2031899 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02066
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT FRACTURE CAN BE THE RESULT OF SEVERE TORQUING OR KINKING OF THE STENT IMPLANT SUCH THAT THERE WOULD BE MATERIAL STRESS/FATIGUE THAT WOULD WEAKEN THE MATERIAL AND RESULT IN A BREAKAGE OF THE STENT IMPLANT. TO HELP ENSURE THIS DAMAGE IS NOT THE RESULT OF THE MANUFACTURING PROCESS, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR DAMAGE AT NUMEROUS POINTS IN THE MANUFACTURING PROCESS. IT IS POSSIBLE THAT OVER INFLATION OR ANATOMICAL CONDITIONS COULD HAVE CONTRIBUTED TO THE REPORTED STENT FRACTURE. IN THIS CASE, THE REPORTED STENT FRACTURE COULD NOT BE CONFIRMED AND A CONCLUSIVE CAUSE CAN NOT BE DETERMINED. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT FRACTURED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1