BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1790947 · Received August 2, 2010

    Report

    Report Number
    2024168-2010-01571
    Event Type
    Death
    Date Received
    August 2, 2010
    Date of Event
    May 13, 2010
    Report Date
    July 8, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 3.5 MONTHS AFTER THE PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED, VIA TRIAL, THAT APPROXIMATELY 3.5 MONTHS POST A FIRST OBTUSE MARGINAL STENTING PROCEDURE WITH A XIENCE STENT, THE PATIENT WAS FOUND AT HOME EXPIRED AND NO AUTOPSY WAS PERFORMED. ACCORDING TO THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS PROBABLE CARDIAC ARRHYTHMIA AND CORONARY ARTERY DISEASE. 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 CLONMEL NA 9090141

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death