BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1706377 · Received May 28, 2010

    Report

    Report Number
    2024168-2010-01084
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    April 25, 2010
    Report Date
    May 21, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINS IN THE PATIENT. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. TIME OF ADVERSE EVENT: APPROX 2 MONTHS POST PROCEDURE. IT WAS REPORTED THAT ON (B) (6) 2010, TWO RX XIENCE V STENTS WERE SUCCESSFULLY IMPLANTED OVERLAPPING IN THE PROXIMAL TO DISTAL LCX. NO PRE-DILATATION WAS PERFORMED. ON (B) (6) 2010, THE PT WAS TAKEN TO ER IN SHOCK. THE PATIENT WAS IMMEDIATELY INTUBATED AND ARTIFICIAL VENTILATION AND HEART MASSAGE WERE PERFORMED; HOWEVER, THE PT DIED OF HEART FAILURE. REPORTEDLY, THE CAUSE OF DEATH MAY HAVE BEEN RELATED TO STENOSIS IN OTHER AREAS OF THE CORONARY. NO ADD'L INFO WAS 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 9102061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| H