BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4122596 · Received September 26, 2014

    Report

    Report Number
    2024168-2014-06235
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. THE DIFFICULTY REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 DIFFICULT TO REMOVE OR SHAFT SEPARATIONS FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE 3.0X20MM TREK REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 98% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). REPORTEDLY, A DISSECTION OCCURRED DURING INFLATION OF THE 3.0X20MM TREK BALLOON DILATATION CATHETER (BDC) AT 12 ATMOSPHERES (ATM). THE 4.0X33MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE DISSECTION; HOWEVER, DURING WITHDRAWAL OF THE SDS, RESISTANCE WAS MET WITH THE GUIDING CATHETER, SLIGHT FORCE WAS APPLIED, AND THE DISTAL SHAFT SEPARATED. AS THE DISTAL SHAFT WAS STUCK IN THE GUIDING CATHETER, ALL DEVICES WERE REMOVED AS A SINGLE UNIT WITHOUT ANY REPORTED ISSUES. THE ACCESS SITE WAS CHANGED FROM RADIAL TO FEMORAL AND THE CASE WAS SUCCESSFULLY COMPLETED. ALTHOUGH THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS, THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE NEED TO CHANGE ACCESS SITE AND GUIDING CATHETER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600982 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3112941

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR