BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3924326 · Received July 9, 2014

    Report

    Report Number
    2024168-2014-04427
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR STENT DISLODGEMENT REPORTED FROM THIS LOT. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USE, VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 3.5X12MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE; HOWEVER, DURING INFLATION, IT WAS NOTED THAT THERE WAS NO STENT IMPLANT ON THE BALLOON. THE SDS WAS DEFLATED AND REMOVED WITHOUT RESISTANCE NOTED. FLUOROSCOPY WAS PERFORMED AND REPORTEDLY, THE STENT IMPLANT WAS NOT FOUND ANYWHERE IN THE PATIENT. IT WAS ASSUMED THAT THE STENT IMPLANT HAD DISLODGED PRIOR TO THE SDS ENTERING THE PATIENT. HOWEVER, THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE SDS FROM THE DISPENSER COIL AND NO RESISTANCE NOTED DURING REMOVAL OF THE STYLET AND PROTECTIVE SHEATH. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER 3.5X12MM XIENCE XPEDITION SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399961 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3060543

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR