BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3000489 · Received March 12, 2013

    Report

    Report Number
    2024168-2013-01422
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 15, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH 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 LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE (B)(6) 2013, WAS OF THE MILDLY TORTUOUS, HEAVILY CALCIFIED, 75% STENOSED, DE NOVO, PROXIMAL RIGHT CORONARY ARTERY (RCA) AND THE 3.0 X 15 MM XIENCE V STENT WAS DEPLOYED WITHOUT REPORTED ISSUE. THE PATIENT WAS HOSPITALIZED WITH COMPLAINTS OF CHEST PAIN. IT WAS NOTED THROUGH ANGIOGRAPHY THAT THE 3.0 X 15 MM XIENCE V STENT HAD STENT THROMBOSIS. ON (B)(6) 2013, A GUIDE WIRE WAS ADVANCED THROUGH THE THROMBOSIS AND ANGIOPLASTY WAS PERFORMED AND TIMI 3 FLOW WAS ACHIEVED. THE PATIENT WAS REPORTED IN STABLE CONDITION AND MEDICAL MANAGEMENT CONTINUED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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
    103943 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2031441

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R