BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4103322 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06081
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 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). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE BMW UNIVERSAL II GUIDE WIRE REFERENCED IS BEING FILED UNDER SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE RESISTANCE WITH THE GUIDE WIRE 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/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. 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 DE NOVO LESION LOCATED IN THE NARROW, HEAVILY CALCIFIED, MID RIGHT CORONARY ARTERY. THE 2.75X28 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) STOPPED ADVANCING ON THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE AND BECAME STUCK WHILE ATTEMPTING TO CROSS. THE SDS AND THE GUIDE WIRE WERE REMOVED AND THE PROCEDURE CONTINUED ON WITH THE USE OF A NEW BMW UNIVERSAL II GUIDE WIRE AND A NON-ABBOTT STENT. 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
    584957 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3120241

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR GUIDE WIRE: BALANCE MIDDLEWEIGHT| GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II