BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5330347 · Received December 28, 2015

    Report

    Report Number
    2024168-2015-08004
    Event Type
    Death
    Date Received
    December 28, 2015
    Date of Event
    September 25, 2014
    Report Date
    January 4, 2016
    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). CONCOMITANT PRODUCTS: STENT: 3.0X14MM NOBORI; 2.25X12MM PROMUS ELEMENT; 2.5X33MM XIENCE XPEDITION, CLOPIDOGREL AND CILOSTAZOL. (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER XIENCE XPEDITION STENT REFERENCED IS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT REFERENCE NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THE PATIENT EFFECTS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF ANGINA, DEATH AND MYOCARDIAL INFARCTION, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. 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 ISSUE WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA ON (B)(6) 2013. ON (B)(6) 2013 100% STENOSIS WAS NOTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND 90% STENOSIS IN THE DISTAL LAD. TWO ABBOTT STENTS WERE IMPLANTED, A 2.5 X 33 MM AND A 35 X 28 MM XIENCE XPEDITION, ALONG WITH SOME NON-ABBOTT STENTS. ON (B)(6) 2014 EFFORT ANGINA WAS REPORTED. ON (B)(6) 2014 A 2.25 X 12 MM NON-ABBOTT STENT WAS IMPLANTED IN THE OBTUSE MARGINAL CORONARY ARTERY. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2014 FOR PLANNED CORONARY ARTERY BYPASS AND PERCUTANEOUS CORONARY INTERVENTION (PCI); HOWEVER, ON (B)(6) 2014 AT 6:45 AM THE PATIENT WENT INTO CARDIOPULMONARY ARREST AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED FOR 1 HOUR. THE PATIENT BECAME UNRESPONSIVE AND AT 7:45 AM EXPIRED. THE CAUSE OF DEATH WAS NOTED AS CARDIAC ARREST DUE TO ACUTE MYOCARDIAL INFARCTION. ADDITIONAL IMAGING WAS PERFORMED AND NO ASCITES OR BRAIN HEMORRHAGE WAS NOTED. CK-MB AND TROPONIN I LEVELS WERE SLIGHTLY ELEVATED. NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853890 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3060741

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death