BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4203836 · Received October 27, 2014

    Report

    Report Number
    2024168-2014-07012
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INFLATION ISSUE OR DEFLATION ISSUE 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 TREATING A NON-TORTUOUS, MODERATELY CALCIFIED, DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. DURING USE OF THE 3.5X33MM XIENCE XPEDITION STENT DELIVERY SYSTEM, THE INFLATION OF THE BALLOON WAS NOTED TO BE SLOW. THE BALLOON WAS FULLY INFLATED AND THE STENT EXPANDED WELL. DURING DEFLATION OF THE BALLOON, DEFLATION WAS NOTED TO BE SLOW; HOWEVER, IT WAS FULLY DEFLATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684849 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4040541

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR GUIDE WIRE: BMW UNIVERSAL .014" 190CM