BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6122233 · Received November 22, 2016

    Report

    Report Number
    2024168-2016-08257
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 22, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648123665
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND DEATH ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE OTHER XIENCE PRIME REFERENCED IS BEING FILED UNDER SEPARATE A MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE WITH IMPLANTATION OF A 3.0 X 38 MM XIENCE PRIME STENT AND A 3.5 X 38 MM XIENCE PRIME STENT. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. ON (B)(6) 2016, THE PATIENT DIED DUE TO STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773159 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 08717648123665

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death STENT: 3.5 X 38 MM XIENCE PRIME