BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4181839 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06771
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR USE AFTER EXPIRATION FROM THIS LOT. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDTION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, ELECTRONIC INSTRUCTIONS FOR USE STATES: NOTE THE USE BY (EXPIRATION) DATE ON THE PRODUCT LABEL. 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 INSTENT RESTENOSIS OF A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 33 MM XIENCE XPEDITON WAS IMPLANTED WHEN IT WAS NOTED THAT THE PRODUCT WAS EXPIRED. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661944 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 208214A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR