BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2123191 · Received June 14, 2011

    Report

    Report Number
    2024168-2011-04165
    Event Type
    Death
    Date Received
    June 14, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. ANGINA, DEATH, AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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 APPROXIMATELY NINETEEN MONTHS POST XIENCE V STENTING PROCEDURE IN THE RAMUS ARTERY WITH ONE 2.5 X 12 STENT AND IN THE RIGHT POSTERIOR DESCENDING ARTERY WITH ONE 2.5 X 23, THE PATIENT EXPERIENCED CHEST PAIN THAT WOKE HIM UP FROM SLEEP. EMERGENCY MEDICAL SERVICES WERE CALLED TO THE HOME, THE PATIENT BECAME WORSE AND DIED AT HOME FROM A MYOCARDIAL INFARCTION ON (B)(6) 2011. THOUGH REQUESTED, 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 9080641

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death STENT: XIENCE V 2.5 X 23