BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1201771 · Received October 15, 2008

    Report

    Report Number
    2024168-2008-00949
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XIENCE V LISTED IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER. RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. ARRHYTHMIA, HYPOTENSION, ISCHEMIA, AND EKG/ECG CHANGES ARE NOT NECESSARILY AN INDICATION OF A STENT DELIVERY SYSTEM QUALITY PROBLEM. IN THIS CASE, THE REPORTED PATIENT ISSUES OF ARRHYTHMIA, HYPOTENSION, ISCHEMIA, AND EKG/ECG CHANGES ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING OR EVEROLIMUS. A CONCLUSIVE ROOT CAUSE FOR ALL REPORTED PATIENT ISSUES, AND THE RELATIONSHIP TO THE DEVICES, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: ARRHYTHMIAS/EKG CHANGES/HYPOTENSION REQUIRING INTRA-CORONARY MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A TRIAL THAT TWO XIENCE V STENTS WERE IMPLANTED IN 2008. UPON COMPLETION OF STENTING AND POST DILATATION, THE PATIENT WENT INTO A JUNCTIONAL RHYTHM (ARRHYTHMIA). THE PATIENT'S ST SEGMENTS WERE ELEVATED (EKG/ECG CHANGES) AND THE PATIENTS BLOOD PRESSURE DROPPED (HYPOTENSION). THE ANGIOGRAM SHOWED NO REFLOW (ISCHEMIA). THE PATIENT WAS TREATED WITH MEDICATION AND NITRO WAS ADMINISTERED INTRACORONARY AND FLOW WAS RESTORED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 7120742

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R XIENCE V 3.5 X 18 MM| LOT #8051961