BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2972263 · Received February 21, 2013

    Report

    Report Number
    2024168-2013-01007
    Event Type
    Death
    Date Received
    February 21, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 30, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, AND DEATH ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS. ALTHOUGH 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. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED TO TREAT A RESTENOSED, PREVIOUSLY STENTED LESION. IT SHOULD BE NOTED THAT THE IFU STATES XIENCE XPEDITION IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. IN THIS CASE, IT IS UNKNOWN IF THE REPORTED IFU DEVIATION DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. THE ADDITIONAL XIENCE XPEDITION ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STABLE ANGINA ON (B)(6) 2013 AT (B)(6). ON ANGIOGRAPHY, 80% IN-STENT RESTENOSIS WAS FOUND IN THE MID RIGHT CORONARY ARTERY (RCA) WHICH WAS TREATED WITH A 3.25 X 18 MM XIENCE XPEDITION STENT. THE DISTAL RCA WAS OBSERVED TO HAVE 80% RESTENOSIS AND WAS TREATED WITH A 3.0 X 15 MM XIENCE XPEDITION STENT. THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY HAD 90% RESTENOSIS AND WAS TREATED WITH A 3.0 X 18 MM XIENCE XPEDITION STENT. THE STENTS WERE CONFIRMED TO BE IMPLANTED SUCCESSFULLY WITH NO ISSUES DURING THE PROCEDURE. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH AN ST-ELEVATED MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS SENT TO THE CATHETERIZATION LAB WHERE IT WAS FOUND THAT THERE WAS STENT THROMBOSIS IN ALL 3 STENTS. AN ASPIRATION DEVICE WAS USED; HOWEVER, THE PATIENT EXPIRED ON THE TABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75401 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death STENT: XIENCE XPEDITION (3.25X18,3.0X18)