BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1665659 · Received April 21, 2010

    Report

    Report Number
    2024168-2010-00817
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    December 26, 2009
    Report Date
    March 27, 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
    IN, US
    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 XIENCE V INSTRUCTIONS FOR USE (IFU) AND NO FAULT RISK ASSESSMENT MATRIX (RAM). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECT AND THE RELATIONSHIP OF THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO THE MANUFACTURE, DESIGN, OR LABELING. THE OTHER RX XIENCE V STENT IS BEING FILED UNDER THIS SAME MFR #.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2008, THE PT UNDERWENT STENTING IN THE PREDILATED MID RIGHT CORONARY ARTERY (RCA) WITH ONE XIENCE V STENT AND IN THE PREDILATED PROXIMAL RCA WITH ONE XIENCE V STENT. THERE WERE NO PROCEDURAL COMPLICATIONS. ON (B) (6) 2009, THE PT DIED OF AN UNK CAUSE. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    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 71129P5

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death RX XIENCE V STENT (P.N. 1009516-28, LOT# 71129P5)