BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2897003 · Received January 4, 2013

    Report

    Report Number
    2024168-2013-00065
    Event Type
    Death
    Date Received
    January 4, 2013
    Date of Event
    January 7, 2012
    Report Date
    December 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND DEATH ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT STENTING IN THE PROXIMAL RIGHT CORONARY ARTERY WITH ONE XIENCE V STENT. ON (B)(6) 2012 THE PATIENT FELT CHEST PAIN THAT DID NOT RESOLVE WITH MEDICATION. THIS WAS CLASSIFIED AS UNSTABLE ANGINA. THE ELECTROCARDIOGRAM AND CARDIAC BIOMARKERS WERE NEGATIVE FOR A MYOCARDIAL INFARCTION (MI). THE PATIENT WAS GIVEN EPINEPHRINE AND OTHER RESCUE MEDICATION ON (B)(6) 2012. THE PATIENT WAS ON DIALYSIS ON (B)(6) 2012. ON (B)(6) 2012 THE PATIENT EXPIRED DUE TO CONGESTIVE HEART FAILURE AND RENAL FAILURE WHILE IN THE NEPHROLOGY DEPARTMENT. AN AUTOPSY WAS NOT PERFORMED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4620 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1052641

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death