BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1357881 · Received April 7, 2009

    Report

    Report Number
    2024168-2009-00596
    Event Type
    Death
    Date Received
    April 7, 2009
    Date of Event
    October 15, 2008
    Report Date
    March 13, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION WAS REPORTED. IT WAS REPORTED THAT IN 2007, THE PT UNDERWENT STENTING OF THE DIST LAD (PRE-DILATED) WITH A XIENCE V STENT. IN 2008, THE PT WAS ADMITTED TO THE HOSPITAL FOR A MASSIVE GI BLEED (EXSANGUINATION DUE TO BLEEDING PEPTIC ULCER AND SEPSIS) AND EXPIRED. ABBOTT MEDICAL ADVISORS ADJUDICATED THE EVENT AS A DEATH POSSIBLE RELATED TO VERY LATE STENT THROMBOSIS AND A NON Q-WAVE MI, UNDETERMINED IF RELATED TO TARGET VESSEL STENT (PT HAD HISTORY OF MULTIPLE PREVIOUS CARDIAC INTERVENTIONS). THEREFORE, THIS EVENT WILL BE CONSERVATIVELY REPORTED FOR THE ADJUDICATIONS RESULTS ONLY. NO ADDITIONAL EVENT OR PT INFO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death