BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2800521 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06671
    Event Type
    Death
    Date Received
    October 22, 2012
    Date of Event
    March 6, 2012
    Report Date
    October 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    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 MYOCARDIAL INFARCTION AND DEATH ARE LISTED IN THE XIENCE V / XIENCE NANO 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) 2008, THE PATIENT UNDERWENT STENTING IN THE DE NOVO, DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH ONE XIENCE V STENT. ON (B)(6) 2012, THE PATIENT WAS FOUND AT HOME UNRESPONSIVE AND INTERMITTENTLY GASPING FOR AIR. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. ACCORDING TO THE ELECTROCARDIOGRAM, THE PATIENT HAD A NON ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS INTUBATED, BUT THE PROGNOSIS WAS POOR AS THE PATIENT REMAINED IN A COMA. COMFORT CARE, INCLUDING MEDICATION, WAS PROVIDED AND THE PATIENT EXPIRED ON (B)(6) 2012. 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 7110841

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death ASPIRIN, CLOPIDOGREL