BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3922334 · Received July 9, 2014

    Report

    Report Number
    2024168-2014-04418
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - USE AFTER EXPIRATION. 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 DEVICE EXPIRATION ISSUE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: DO NOT USE AFTER THE USE BY (EXPIRATION) DATE. POTENTIAL ADVERSE EVENTS WITH USING THE DEVICE POST-EXPIRATION DATE INCLUDE INFECTION AND STENOSIS/RESTENOSIS. IN THIS CASE, THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3.5 X 12 MM XIENCE XPEDITION STENT WAS IMPLANTED WITHOUT ISSUE. AFTER THE PROCEDURE, IT WAS NOTED THAT THE STENT HAD EXPIRED THE PREVIOUS DAY. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400309 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3053042

    Patients

    Seq Age Sex Outcome Treatment
    1