BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4298839 · Received December 4, 2014

    Report

    Report Number
    2024168-2014-07956
    Event Type
    Injury
    Date Received
    December 4, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 12, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE REPORTED DEVICE WAS A NON-ABBOTT DEVICE; THEREFORE NO EVALUATION IS NEEDED.

    Description of Event or Problem · 1

    THE XIENCE XPEDITION STENT DISLODGED FROM THE STENT DELIVERY SYSTEM BALLOON. IT IS UNKNOWN AT THIS TIME IF THE STENT REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, ADDITIONAL INFORMATION RECEIVED REPORTED THAT FOR THIS CASE, IT WAS NOT AN ABBOTT VASCULAR DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783792 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other STENT: MEDTRONICS RESOLUTE