BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3081154 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02623
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    January 1, 2011
    Report Date
    February 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) 2011 - ESTIMATED DATE OF EVENT. (B)(6) 2008 - ESTIMATED DATE OF IMPLANT. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF OCCLUSION, AS LISTED IN THE ELECTRONIC XIENCE V / XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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. THE TWO OTHER XIENCE V DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESEARCH PATHOLOGY OF AN EXPLANTED HEART FOUND 3 UNK XIENCE STENTS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE XIENCE STENTS SHOWED NEOATHEROSCLEROSIS. THE CAUSE OF DEATH WAS NONCARDIAC DEATH. THE EVENTS OCCURRED 1081 DAYS POST STENT IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182211 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other STENT: XIENCE (X2)