BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2210804 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05707
    Event Type
    Death
    Date Received
    August 12, 2011
    Date of Event
    May 10, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THE REPORTED DEATH IS A KNOWN ADVERSE EVENT LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FIFTEEN MONTHS POST XIENCE V STENTING PROCEDURE IN THE MID RIGHT CORONARY ARTERY WITH ONE 3.0 X 28 MM STENT AND IN THE PROXIMAL RIGHT CORONARY ARTERY WITH ONE 3.5 X 12 MM STENT, THE PATIENT DIED AT HOME. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN. 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 9080441

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death STENT: XIENCE V 3.5 X 12, VISION AND MINI VISION