BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3933027 · Received July 14, 2014

    Report

    Report Number
    2024168-2014-04508
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEAVILY TORTUOUS, MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY PROCEDURE, WHILE DEPLOYING THE 4.0 X 38 MM XIENCE XPEDITION A SMALL DISSECTION IN THE VESSEL OCCURRED. ANOTHER XIENCE XPEDITION WAS USED TO COVER THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410316 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4030341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention