BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3170812 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03738
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FAILURE TO FOLLOW STEPS (INSPECT DEVICE PRIOR TO USE). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DISLODGED STENT IMPLANT WAS RETURNED FOR ANALYSIS, THUS CONFIRMING THE DISLODGEMENT. THE REPORT THAT THE STYLET AND STENT IMPLANT WERE STUCK/FUSED TOGETHER WAS NOT CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS, 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: PRIOR TO USE, VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STENT DELIVERY SYSTEM WAS LOADED ONTO THE GUIDE WIRE, PRIOR TO ENTERING THE PATIENT, IT WAS OBSERVED THAT THERE WAS NO STENT IMPLANT ON THE 4.0X15 MM XIENCE XPEDITION BALLOON. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE FROM THE GUIDE WIRE AND ANOTHER SAME SIZE XIENCE XPEDITION WAS USED WITHOUT ISSUE. UPON VISUAL INVESTIGATION, THE STENT IMPLANT APPEARED TO BE FUSED TO THE STYLET. NO ADVERSE PATIENT EFFECTS, OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271465 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112241

    Patients

    Seq Age Sex Outcome Treatment
    1