BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1980446 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00726
    Event Type
    Death
    Date Received
    February 7, 2011
    Date of Event
    June 3, 2010
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS INSIDE THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, ISCHEMIA, MYOCARDIAL INFARCTION, DEATH, CARDIOGENIC SHOCK, VENTRICULAR TACHYCARDIA, ARRHYTHMIA, AND HYPOTENSION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT STENTING IN THE PREDILATED PROXIMAL LEFT CIRCUMFLEX ARTERY WITH ONE XIENCE V STENT. ON (B)(6) 2010, THE PATIENT WAS ADMITTED WITH CHEST PAIN AND WAS FOUND TO HAVE HAD AN ST AND Q-WAVE MYOCARDIAL INFARCTION (MI). THE ECHOCARDIOGRAM SHOWED A LEFT VENTRICULAR EJECTION FRACTION OF 10% TO 20%. THE PATIENT'S HEMOGLOBIN AND HEMATOCRIT WAS LOW AND THE PATIENT WAS TRANSFUSED WITH 7 UNITS OF BLOOD. ON (B)(6) 2010, THE PATIENT'S PULSE RATE AND BLOOD PRESSURE DROPPED. THE PATIENT HAD RUNS OF VENTRICULAR TACHYCARDIA AND THE PATIENT EXPIRED SECONDARY TO CARDIOGENIC SHOCK AND THE MI. AN AUTOPSY REPORT WAS NOT AVAILABLE. 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 9071742

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death