BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2152516 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04809
    Event Type
    Death
    Date Received
    July 7, 2011
    Date of Event
    March 18, 2011
    Report Date
    June 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH IS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST XIENCE V STENT IMPLANTATION IN THE 3RD OBTUSE MARGINAL ARTERY, THE PATIENT DID NOT EXPERIENCE ANY SIGNIFICANT ADVERSE EVENTS; HOWEVER, APPROXIMATELY 4 YEARS AND NINE MONTHS AFTER STENT IMPLANTATION, THE PATIENT DIED IN THEIR SLEEP. NO AUTOPSY WAS PERFORMED. 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 60609P1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death