BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4102108 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06046
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 26, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE PRIME 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 THE PROCEDURE WAS TREATING A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 95% STENOSED, DE NOVO LESION IN THE OBTUSE MARGINAL CORONARY ARTERY. PRE-DILATATION WAS PERFORMED USING A 1.5X12MM BALLOON. DURING USE OF THE 2.75X28MM XIENCE PRIME, A DISTAL EDGE DISSECTION OCCURED. THE DISSECTION WAS TREATED WITH ANOTHER XIENCE PRIME STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584592 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3111641

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention