BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2821765 · Received November 6, 2012

    Report

    Report Number
    2024168-2012-07000
    Event Type
    Death
    Date Received
    November 6, 2012
    Date of Event
    January 11, 2012
    Report Date
    October 16, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. 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 OVER 3 YEARS POST XIENCE V STENT IMPLANTATION IN THE SECOND OBTUSE MARGINAL ARTERY, THE PATIENT DIED AT HOME. CAUSE OF DEATH WAS NOT PROVIDED. AN AUTOPSY WAS NOT PERFORMED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. NOTE: POST STENT IMPLANTATION, ENZYMES WERE ELEVATED. THERE WAS NO REPORT OF PERMANENT IMPAIRMENT OR INTERVENTION. 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 8050961

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death