BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4093622 · Received September 16, 2014

    Report

    Report Number
    2024168-2014-05960
    Event Type
    Death
    Date Received
    September 16, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. CARDIAC ARREST AND DEATH ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON 10/31/2013 A 2.25 X 18 MM XIENCE PRIME SV WAS IMPLANTED IN A HIGH LATERAL BRANCH AND A 2.75 X 8 MM XIENCE XPEDITION WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY. ON (B)(6) 2014 THE PATIENT PRESENTED WITH CARDIOPULMONARY ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED; HOWEVER, THE PATIENT EXPIRED. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573296 XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death STENT: 2.75 X 8 XIENCE XPEDITION