BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5241995 · Received November 22, 2015

    Report

    Report Number
    2024168-2015-07068
    Event Type
    Injury
    Date Received
    November 22, 2015
    Date of Event
    October 29, 2015
    Report Date
    November 22, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. 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 HYPERSENSITIVITY (ALLERGIC REACTION) AND THROMBOSIS, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE 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. (B)(4). THE 3.0X38MM 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 MILDLY TORTUOUS AND MODERATELY CALCIFIED MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0 X 38 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE MID LAD, AND A 3.5 X 12 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PROXIMAL LAD. DURING THE PROCEDURE, THE PATIENT DEVELOPED A RASH. AS THE PROCEDURE CONTINUED, THROMBOSIS WAS OBSERVED IN BOTH STENT IMPLANTS. IT IS UNKNOWN HOW THE THROMBOSIS WAS TREATED. THE PATIENT WAS ADMINISTERED HYDROCORTISONE AND A TIROFIBAN INFUSION FOR 12 HOURS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR IMMUNOLOGY REVIEW. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772103 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 5070241

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R