BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3063530 · Received April 17, 2013

    Report

    Report Number
    2024168-2013-02355
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE OTHER XIENCE XPEDITION DEVICE REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE DEVICE WAS RETURNED FOR ANALYSIS. THE BROKEN SHAFT WAS ABLE TO BE CONFIRMED AS THE HYPOTUBE WAS SEPARATED. 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST XIENCE XPEDITION STENT DELIVERY SYSTEM WAS REMOVED FROM THE HOOP AND IT WAS NOTED THAT THE CATHETER WAS BROKEN. THE DEVICE WAS NOT USED. THE SECOND XIENCE XPEDITION WAS THEN REMOVED FROM THE HOOP AND THIS DEVICE CATHETER WAS ALSO NOTED TO BE BROKEN. THIS DEVICE WAS NOT USED. A NEW UNSPECIFIED SIZE XIENCE XPEDITION WAS THEN USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165972 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2092641

    Patients

    Seq Age Sex Outcome Treatment
    1