BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2951123 · Received February 8, 2013

    Report

    Report Number
    2024168-2013-00761
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS. 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 ON (B)(6) 2012, DURING A PROCEDURE OF THE MILDLY TORTUOUS, DE NOVO, OSTIAL TO MID RAMUS DIFFUSED LESION, A 2.25 X 15 MM XIENCE V STENT WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT PRESENTED ON (B)(6) 2013 WITH COMPLAINTS OF CHEST DISCOMFORT AND ANGIOGRAPHY REVEALED MID IN-STENT RESTENOSIS. THE PATIENT IS CURRENTLY BEING TREATED WITH MEDICATION ONLY. THE PATIENTS CONDITION HAS BEEN NOTED AS STABLE AND DOING FINE. THERE WAS NO ADVERSE PATIENT EFFECTS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54080 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1120841

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R