BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3170648 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03735
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    March 29, 2013
    Report Date
    May 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF DEATH AND MYOCARDIAL INFARCTION, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURE. 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS ((B)(6) 2013) POST XIENCE V STENT IMPLANTATION IN THE LEFT MAIN AND PROXIMAL RIGHT CORONARY ARTERY, THE PATIENT EXPERIENCED A GASTROINTESTINAL BLEED AND WAS HOSPITALIZED. ON (B)(6) 2013, THE PATIENT WAS WORKING IN THEIR YARD AND WENT DOWN. EMERGENCY SERVICES WERE CALLED. UPON ARRIVAL, THE PATIENT WAS PULSELESS AND UNRESPONSIVE. CARDIOPULMONARY RESUSCITION, INCLUDING MEDICATION WAS INITIATED AND THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT. EFFORTS TO RESUSCITATE WERE UNSUCCESSFUL AND THE PATIENT WAS PRONOUNCED DEAD. AN AUTOPSY WAS NOT PERFORMED. CAUSE OF DEATH WAS NOTED TO BE ACUTE CORONARY INSUFFICIENCY AND MYOCARDIAL INFARCTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271583 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2042341

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death STENT: XIENCE V 4.0 X 15MM