BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1980163 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00720
    Event Type
    Death
    Date Received
    February 7, 2011
    Date of Event
    August 27, 2010
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO PRE-DILATATION (DIRECT STENTING). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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. SINCE IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED VIA DIRECT STENTING, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. IN THIS CASE, IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT DIRECT STENTING IN THE PROXIMAL RIGHT CORONARY ARTERY WITH ONE 2.5 X 12 MM XIENCE V STENT. ON (B)(6) 2010, THE PATIENT DIED. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN. THOUGH 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 DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8091261

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death