BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1790929 · Received August 3, 2010

    Report

    Report Number
    2024168-2010-01574
    Event Type
    Death
    Date Received
    August 3, 2010
    Date of Event
    December 27, 2009
    Report Date
    July 9, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE DESIGN, OR LABELING.

    Description of Event or Problem · 1

    ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: APPROXIMATELY 17 MONTHS POST PROCEDURE,. DEVICE ISSUE: NONE. IT WAS REPORTED, VIA TRIAL, THAT APPROXIMATELY 17 MONTHS POST A LEFT MAIN CORONARY ARTERY STENTING PROCEDURE WITH A XIENCE STENT, THE PATIENT EXPIRED. CAUSE OF DEATH WAS CARDIAC ARREST FROM PRE-EXISTING CAUSES OF ARTERIOSCLEROTIC HEART DISEASE, CONGESTIVE HEART FAILURE AND DIABETES. THE PATIENT DIED AT A NURSING HOME AND NO AUTOPSY WILL BE PERFORMED. ALTHOUGH REQUESTED, 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 7121061

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death STENT: TAXUS