BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001911 · Received February 27, 2011

    Report

    Report Number
    2024168-2011-01228
    Event Type
    Death
    Date Received
    February 27, 2011
    Date of Event
    October 13, 2009
    Report Date
    October 16, 2009
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINED IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, MYOCARDIAL INFARCTION, THROMBOSIS, HYPOTENSION, AND DEATH ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). 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 OR DESIGN. IT WAS REPORTED THE LESION WAS NOT PRE-DILATED PRIOR TO IMPLANTATION OF THE XIENCE V STENT. IT SHOULD BE NOTED THE IFU STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER. IT IS UNKNOWN HOW THE FAILURE TO PRE-DILATE THE LESION MAY HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT DIRECT STENTING IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH THE 2.75 X 28 MM XIENCE V FIRST AND A 3.0 X 23 MM XIENCE V SECOND. ON (B)(6) 2009, THE PATIENT WAS READMITTED TO THE HOSPITAL DUE TO CHEST PAIN, HYPOTENSION, AND RESPIRATORY DISTRESS. CARDIAC ENZYMES WERE ELEVATED AND THE ELECTROCARDIOGRAM (ECG) WAS POSITIVE FOR A MYOCARDIAL INFARCTION (MI). THE PATIENT WAS DIAGNOSED WITH ISCHEMIC CARDIOMYOPATHY WITH CARDIOGENIC SHOCK AND A DIAGNOSTIC CORONARY ANGIOGRAM WAS NOT PERFORMED. THE PATIENT WAS TREATED WITH A PACEMAKER, INOTROPES, AND VASOPRESSOR SUPPORT. THE PATIENT'S FAMILY REQUESTED NO FURTHER AGGRESSIVE MEASURES AND THE PATIENT EXPIRED ON (B)(6) 2009 AFTER HAVING ONE EPISODE OF HEMATEMESIS. CPR WAS NOT PERFORMED. NEITHER A DEATH CERTIFICATE, NOR AN AUTOPSY REPORT IS AVAILABLE. THE CLINICAL EVENTS COMMITTEE ADJUDICATED THIS EVENT AS A NON Q WAVE MI AND A POSSIBLE LATE STENT THROMBOSIS. IT WAS UNDETERMINED IF THE MI WAS CAUSED BY THE TARGET VESSEL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8040461

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death STENT: 3.0 X 23 MM RX XIENCE V ((B)(4))