BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3081372 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02633
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    January 1, 2012
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED DATE OF IMPLANT: (B)(6) 2011. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF DEATH AND THROMBOSIS, AS LISTED IN THE ELECTRONIC XIENCE V / XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS 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 SEVEN 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 8 UNK XIENCE STENTS IMPLANTED IN THE PROXIMAL-DISTAL RIGHT CORONARY ARTERY. STENT THROMBOSIS WAS FOUND. THE CAUSE OF DEATH WAS STENT RELATED DEATH. THE EVENTS OCCURRED 14 DAYS POST STENT IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181051 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death XIENCE STENT (X7)