BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3053361 · Received April 11, 2013

    Report

    Report Number
    2024168-2013-02202
    Event Type
    Death
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). STENT: XIENCE V 2.5X28, XIENCE V 2.5X15, (2) XIENCE V 2.5X18. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. IN THIS CASE, THE DEATH OCCURRED 4 YRS 5 MONTHS POST-PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED THAT THE PATIENT EXPIRED FROM A LOWER RESPIRATORY INFECTION LISTED AS BRONCHIAL PNEUMONIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, TWO XIENCE V STENTS WERE IMPLANTED IN A MID LEFT ANTERIOR DESCENDING ARTERY (LAD), ONE XIENCE V STENT WAS IMPLANTED IN A PROXIMAL LAD, ONE XIENCE V STENT WAS IMPLANTED IN A FIRST OBTUSE MARGINAL ARTERY (OM1), AND ONE XIENCE STENT IN A PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). APPROXIMATELY, 4 YRS 5 MONTHS LATER, ON (B)(6) 2013, THE PATIENT EXPIRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155847 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8050841

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death CONCOMITANT MEDICAL DEVICES