BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3942490 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04602
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    February 7, 2014
    Report Date
    July 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) 2014: (14:01) CREATININE KINASE-MYOCARDIAL BAND (CK-MB)=1.4 NG/ML, NORMAL UPPER LIMIT 6.3. (B)(6) 2014: CENTRAL LAB CK=62 U/L, NORMAL UPPER LIMIT 397. (B)(6) 2014: CENTRAL LAB CK-MB=2.1 NG/ML, NORMAL UPPER LIMIT 6.32. CONCOMITANT MEDICAL PRODUCTS: STENT: OTW XIENCE XPEDITION 3.0X28MM. OTHER: CLOPIDOGREL, ASPIRIN, BIVALIRUDIN. THE 3.0 X 28 MM OTW XIENCE XPEDITION IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF CORONARY STENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANTATION OF TWO OVERLAPPING XIENCE XPEDITION STENTS IN THE MID RIGHT CORONARY ARTERY, THE PATIENT EXPERIENCED CHEST PAIN AND WAS TAKEN BACK TO THE CATHETER LAB. THE STENTS WERE NOTED TO BE WELL APPOSED TO THE VESSEL WALL. STENT THROMBOSIS WAS NOTED IN THE MID AND DISTAL PORTION OF THE STENTED REGION. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS SUCCESSFULLY PERFORMED, RESOLVING THE EVENT. HOSPITAL STAY WAS NOT NOTED TO BE PROLONGED AND TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED HOME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418076 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3101542

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention