BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1309975 · Received February 10, 2009

    Report

    Report Number
    2024168-2009-00202
    Event Type
    Death
    Date Received
    February 10, 2009
    Date of Event
    January 2, 2009
    Report Date
    January 15, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XIENCE V RX 2.75 X 08 MM (LOT# 8052641) IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: THE PATIENT HAD A CARDIAC ARREST AND DIED. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT THE PATIENT HAD A 3.0 X 15 MM AND A 2.75 X 08 MM RX XIENCE V STENT IMPLANTED IN 2008. IN EARLY 2009, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF EPITAXIS [NOSEBLEED] AND SUDDENLY WENT INTO CARDIAC ARREST. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT AFTER ACLS [ADVANCED CARDIAC LIFE SUPPORT] PROTOCOL WAS PERFORMED, VASOPRESSOR IV GTT, AND THE PATIENT WAS INTUBATED; HOWEVER, THE PATIENT DIED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS 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 8052161

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| H| L| R XIENCE V RX 2.75 X 08 MM| LOT# 8052641