BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3833330 · Received May 27, 2014

    Report

    Report Number
    2024168-2014-03341
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS. EVALUATION SUMMARY: THE STENT IMPLANT WAS RETURNED FOR EVALUATION. STENT DISLODGEMENT WAS CONFIRMED. BASED ON A VISUAL/DIMENSIONAL ANALYSIS INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USING THE DEVICE, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED. HOWEVER, DO NOT MANIPULATE, TOUCH, OR HANDLE THE STENT WITH YOUR FINGERS. IT MAY CAUSE COATING DAMAGE, CONTAMINATION OR STENT DISLODGEMENT FROM THE DELIVERY BALLOON. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN AN UNSPECIFIED VESSEL. THE 3.25X23MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND WAS PRESSURIZED. AFTER INTRAVASCULAR ULTRASOUND (IVUS), THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE FOLLOWING DAY, ANGIOGRAPHY WAS REVIEWED AND IT WAS NOTED FOR THE FIRST TIME THAT THE STENT IMPLANT WAS NOT IN THE LESION. THE GARBAGE BIN WAS CHECKED AND THE STENT IMPLANT WAS FOUND INSIDE THE PROTECTIVE SHEATH, AS IT HAD DISLODGED DURING UNPACKING. IT IS CURRENTLY UNKNOWN IF ADDITIONAL PERCUTANEOUS CORONARY INTERVENTION (PCI) WILL BE PERFORMED IN THE FUTURE TO DEPLOY A STENT IMPLANT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311652 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3022741

    Patients

    Seq Age Sex Outcome Treatment
    1