BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3250452 · Received July 26, 2013

    Report

    Report Number
    2024168-2013-04704
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC MID AND PROXIMAL RIGHT CORONARY ARTERY. ON (B)(6) 2013 A 3.0 X 28 MM XIENCE PRIME WAS IMPLANTED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY. POST-DILATATION WAS PERFORMED AND USING INTRAVASCULAR ULTRASOUND (IVUS), THE STENT WAS CONFIRMED TO BE FULLY APPOSED. ON (B)(6) 2013 THE PATIENT EXPERIENCED CHEST PAIN. ANGIOGRAPHY WAS PERFORMED AND IN-STENT THROMBOSIS WAS CONFIRMED. A NON-ABBOTT STENT WAS IMPLANTED TO TREAT THE THROMBOSIS. THE PATIENT'S CONDITION WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349761 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2091841

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R