BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3870532 · Received June 12, 2014

    Report

    Report Number
    2024168-2014-03766
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT OF A 2.50X18MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS), THE STENT DISLODGED. THE PHYSICIAN, UNSUCCESSFULLY, ATTEMPTED TO REMOVE THE DISLODGED STENT VIA SNARE. THE DISLODGED STENT WAS APPOSED TO AN UNINTENDED AND UNSPECIFIED SITE, VIA A DILATATION CATHETER. A 2.5X12MM XIENCE XPEDITION STENT SUCCESSFULLY TREATED THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. THERE WAS A CLINICALLY SIGNIFICANT DELAY. THERE WERE NO OTHER ADVERSE EVENTS REPORTED. THERE WAS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348479 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention