BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1542945 · Received November 19, 2009

    Report

    Report Number
    2024168-2009-02166
    Event Type
    Death
    Date Received
    November 19, 2009
    Date of Event
    July 25, 2009
    Report Date
    October 27, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE XIENCE V 3.0 X 15 MM (PART# 1009541-15/LOT# 8052161) AND XIENCE V 3.5 X 15 MM (PART# 1009542-15/LOT# 8050961) MENTIONED ARE BEING FILED UNDER THE SAME MANUFACTURER NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: THE PT DIED, AND IT IS UNK FOR CERTAIN IF IT WAS DEVICE RELATED. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL, THAT THREE XIENCE V STENTS (TWO XIENCE V 3.5 X 15 AND ONE XIENCE V 3.0 X 15 MM) WERE IMPLANTED IN THE PT IN 2008. THE PT WAS ADMITTED TO THE HOSPITAL IN 2009, FOR SYMPTOMS RELATED TO CONGESTIVE HEART FAILURE (CHF). THE PT WAS TREATED AND DISCHARGED TO A NURSING HOME THE FOLLOWING MONTH. HIS SYMPTOMS PROGRESSED, AND HE WAS TAKEN TO AN OUTLYING FACILITY THREE DAYS LATER, WHERE THE PT DIED. NO ADDITIONAL EVENT OR PT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8051941

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death XIENCE V 3.5 X 15 MM (PART#1009542-15/LOT#8050961)| XIENCE V 3.0 X 15 MM (PART#1009541-15/LOT#8052161)