BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1638580 · Received March 22, 2010

    Report

    Report Number
    2024168-2010-00551
    Event Type
    Death
    Date Received
    March 22, 2010
    Date of Event
    November 24, 2008
    Report Date
    February 25, 2010
    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
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE RX XIENCE V 3.0 X 23 MM (PART# 1009529-23/LOT# 6072951) AND RX XIENCE V 3.5 X 12 MM (PART# 1009530-12/LOT# 6081751) MENTIONED ARE BEING FILED UNDER THE SAME MANUFACTURER NUMBER. THE STENTS REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: APPROXIMATELY 20 MONTHS POST PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2007 THE PATIENT UNDERWENT STENTING OF THE MID LEFT ANTERIOR DESCENDING ARTERY WITH ONE XIENCE V STENT, DISTAL CIRCUMFLEX ARTERY WITH ONE XIENCE V STENT, A PROXIMAL CIRCUMFLEX ARTERY WITH ONE XIENCE V STENT. ON (B) (6) 2008, THE PATIENT FELL, WAS HOSPITALIZED AND EXPIRED ON (B) (6) 2008. ABBOTT VASCULAR MEDICAL SAFETY MONITORS ASSESSED THIS EVENT AS A POSSIBLE VERY LATE STENT THROMBOSIS. THERE WAS NO ADDITIONAL INFORMATION 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 6071151

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H RX XIENCE V 3.5 X 12 MM| (PART# 1009529-23/LOT# 6072951)| RX XIENCE V 3.0 X 23 MM| (PART# 1009530-12/LOT# 6081751)