BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1760703 · Received July 14, 2010

    Report

    Report Number
    2024168-2010-01397
    Event Type
    Death
    Date Received
    July 14, 2010
    Date of Event
    October 3, 2009
    Report Date
    June 19, 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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINS IN THE P'T'S BODY. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: APPROX 15 MONTHS POST PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2008, THE PT UNDERWENT STENTING IN THE PREDILATED MID LEFT ANTERIOR DESCENDING ARTERY WITH ONE XIENCE V STENT. ON (B) (6) 2009, THE PT DIED OF CARDIAC ARREST TEN MINUTES BEFORE ARRIVING TO THE EMERGENCY ROOM DESPITE RESUSCITATION ATTEMPTS AND INTUBATION. 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 NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 71203P8

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death