BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4141133 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06433
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 18, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENTS BIRTH YEAR WAS PROVIDED AS 1953. THE PATIENTS AGE WAS ESTIMATED AS (B)(6). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THROMBOSIS IS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE 3.0X15MM XIENCE XPEDITION STENT, REFERENCED WAS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.75X28MM AND 3.0X15MM, XIENCE XPEDITION STENTS, WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY, CHRONICALLY OCCLUDED LESION. APPROXIMATELY 7 HOURS POST PROCEDURE, A THROMBUS WAS NOTED IN THE STENTS. A PRONTO EXTRACTION CATHETER WAS USED TO EXTRACT THE THROMBUS AND BALLOON ANGIOPLASTY WAS PERFORMED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618492 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 3.0X15MM XIENCE XPEDITION STENT