BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3930420 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04492
    Event Type
    Death
    Date Received
    July 11, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 18, 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). CONCOMITANT PRODUCTS: GUIDE WIRE: SION BLUE, RUNTHROUGH EXTRA FLOPPY; GUIDE CATH: HEARTRAIL II JL4.0. IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED PATIENT EFFECTS OF ANGINA, DEATH, SHOCK AND THROMBOSIS AS LISTED IN THE XIENCE XPEDITION DRUG ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF A CORONARY STENTS IN NATIVE CORONARY ARTERIES. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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. THE OTHER XIENCE XPEDITION REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED HIGH LATERAL OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD), AND A 90% STENOSED PROXIMAL LAD. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 WITH ACUTE CORONARY SYNDROME (ACS). ON (B)(6) 2014 A 2.5 X 15 MM XIENCE XPEDITION WAS IMPLANTED IN THE SECOND DIAGONAL OF THE LAD. ON (B)(6) 2014, A 2.5 X 33 MM XIENCE XPEDITION WAS PLACED IN THE PROXIMAL LAD. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014 THE PATIENT PRESENTED WITH CHEST PAIN AND SHOCK. IT WAS CONFIRMED THERE WAS THROMBOSIS IN BOTH OF THE XIENCE XPEDITION STENTS. AN INTRA-AORTIC BALLOON PUMP WAS USED FOR INTUBATION. ON (B)(6) 2014, CORONARY ANGIOGRAPHY AND SWAN-GANZ WERE PERFORMED AND THE PATIENT DIED ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406157 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4021941

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death CONCOMITANT MEDICAL DEVICES