BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1656776 · Received April 8, 2010

    Report

    Report Number
    2024168-2010-00722
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 29, 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). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE 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

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: APPROXIMATELY 3-4 YEARS POST PROCEDURE. IT WAS REPORTED THAT THE 2.5 X 28 MM XIENCE V WAS SUCCESSFULLY IMPLANTED ON (B) (6) 2006, IN THE RIGHT CORONARY ARTERY (RCA), IN THE POSTEROLATERAL SEGMENT ARTERY (PLSA). THE PATIENT DIED OF UNKNOWN CAUSES 3-4 YEARS POST STENTING PROCEDURE. THE EXACT DATE OF DEATH AND CAUSE OF DEATH WERE NOT REPORTED. 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 51031P2

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death