BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1714139 · Received June 7, 2010

    Report

    Report Number
    2024168-2010-01125
    Event Type
    Death
    Date Received
    June 7, 2010
    Date of Event
    April 17, 2010
    Report Date
    May 13, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE 4.0 X 28MM XIENCE V SENT MENTIONED IS BEING REPORTED UNDER THIS SAME MEDWATCH REPORT NUMBER. THE 2.5 X 8MM XIENCE V STENT MENTIONED IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. IN THIS CASE, THERE WAS NO REPORTED DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT 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

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. TIME OF ADVERSE EVENT: APPROXIMATELY 16 MONTHS POST PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2008, THE PT UNDERWENT STENTING OF THE PRE-DILATED MID LEFT ANTERIOR DESCENDING ARTERY WITH A 2.5 X 8 RX XIENCE V STENT AND THE PRE-DILATED PROXIMAL RIGHT CORONARY ARTERY WITH A 4.0 X 12 OTW XIENCE V STENT AND 4.0 X 28 OTW XIENCE V STENT. ON (B) (6) 2010, THE PT EXPIRED. DETAILS SURROUNDING THE DEATH ARE UNK. THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE IS DEMENTIA. NO ADDITIONAL 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 8031161

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death (P.N. 1009549-28, LOT# 7113061)| 2.5 X 8 MM XIENCE V (P.N. 1009539-08, LOT#7101641)| 4.0 X 28 MM XIENCE V: