BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3043599 · Received April 9, 2013

    Report

    Report Number
    2024168-2013-02110
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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. ESTIMATED DATE OF EVENT. 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 WHILE PULLING A 3.5X15 RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) FROM ITS DISPENSER HOOP, WITHOUT RESISTANCE FELT, THE END OF THE DISPENSER HOOP SNAGGED THE STENT AND PROTECTIVE SHEATH, COMPLETELY DISLODGING THE STENT FROM ITS BALLOON. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER RX XIENCE XPEDITION STENT WAS UNPACKAGED AND USED WITHOUT ISSUE IN COMPLETING THE PROCEDURE. THERE WAS NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147105 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1