BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2802199 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06710
    Event Type
    Death
    Date Received
    October 23, 2012
    Date of Event
    January 6, 2011
    Report Date
    October 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 EFFECT OF DEATH IS LISTED IN THE XIENCE V / XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 PREDILATED, DE NOVO, PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH ONE XIENCE V STENT. ON (B)(6) 2011 THE PATIENT, WHO EXPERIENCED WORSENING CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND DECLINED INTUBATION, WAS TRANSFERRED TO HOSPICE AFTER BEING MADE A DO NOT RESUSCITATE STATUS. THE PATIENT EXPIRED ON (B)(6) 2011. 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 7110641

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death ASPIRIN