BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3953875 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04727
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT DISLODGEMENT WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL 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/REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR STENT DISLODGEMENTS FROM THIS LOT. IT SHOULD BE NOTED THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USING THE XIENCE XPEDITION STENT SYSTEM, 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. 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 A LESION LOCATED IN THE RIGHT CORONARY ARTERY. AFTER PREPPING THE 3.5X18 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) AND ADVANCEMENT OF THE SDS ONTO THE GUIDE WIRE IT WAS OBSERVED THAT THERE WAS NO STENT ON THE BALLOON. INVESTIGATION FOUND THE STENT IMPLANT LOCATED INSIDE THE PROTECTIVE SHEATH. THERE WAS NO REPORTED RESISTANCE FELT DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE BALLOON AND STENT. THE DEVICE WAS NOT USED IN THE PATIENT. THE SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431622 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3121142

    Patients

    Seq Age Sex Outcome Treatment
    1