BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4100327 · Received September 18, 2014

    Report

    Report Number
    2024168-2014-06033
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DISLODGED STENT WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL AND DIMENSIONAL 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 COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR DISLODGED STENT FROM THIS LOT. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USING THE XIENCE XPEDITION STENT SYSTEM, 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 DURING A PROCEDURE OF THE UNSPECIFIED VESSEL AFTER DEVICE PREPARATION THE 3.25 X 15 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ON THE GUIDE WIRE THROUGH THE GUIDE CATHETER WHEN IT WAS NOTED UNDER FLUOROSCOPY THAT THE STENT HAD DISLODGED FROM THE BALLOON. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. OUTSIDE THE ANATOMY THE STENT IMPLANT WAS FOUND INSIDE THE PROTECTIVE SHEATH. THERE WAS NO RESISTANCE REPORTED DURING PROTECTIVE SHEATH REMOVAL AND DEVICE PREPARATION. A SECOND SDS WAS USED IN THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580052 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3102441

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR