BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2060105 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02652
    Event Type
    Death
    Date Received
    April 15, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    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. STENT: 2.5X12 XIENCE V ((B)(4)). OTHER: ASPIRIN 325 MG, CLOPIDOGREL 75 MG. THE STENT REMAINED IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH AND THROMBOSIS ARE LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IT WAS REPORTED THAT THE XIENCE STENT WAS IMPLANTED IN A RESTENOSED STENT. IT SHOULD BE NOTED THAT THE IFU STATES THAT THE XIENCE V STENT IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. IT IS UNKNOWN, HOW IF AT ALL, USE OF THE XIENCE IN A RESTENOSIS, CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, 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 VIA A TRIAL THAT ON (B)(6) 2008 THE PATIENT UNDERWENT STENTING IN THE PRE-DILATED, RESTENOSED, HEAVILY CALCIFIED AND TORTUOUS, MID RIGHT CORONARY ARTERY (RCA) WITH ONE 2.5 X 18 MM XIENCE V STENT AND ONE 2.5 X 12 MM XIENCE V STENT. ON (B)(6) 2011, THE PATIENT EXPIRED OF AN UNKNOWN CAUSE. AN AUTOPSY REPORT WAS NOT AVAILABLE. THE ABBOTT VASCULAR CLINICAL EVENTS COMMITTEE ADJUDICATED THIS EVENT AS A POSSIBLE, VERY LATE, STENT THROMBOSIS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8050841

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death