BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 9857883 · Received March 19, 2020

    Report

    Report Number
    2024168-2020-02688
    Event Type
    Death
    Date Received
    March 19, 2020
    Date of Event
    September 16, 2013
    Report Date
    July 28, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.

    Additional Manufacturer Narrative · 0

    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 PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF DEATH IS LISTED IN THE XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF CARDIAC ARREST, DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    ¿TREATMENT WITH 48-MM EVEROLIMUS-ELUTING STENTS PROCEDURAL SAFETY AND 12-MONTH PATIENT OUTCOME" THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.NA

    Description of Event or Problem · 1

    AN INDIVIDUAL PATIENT WAS REPORTED THROUGH A RESEARCH ARTICLE TITLED ¿TREATMENT WITH 48-MM EVEROLIMUS-ELUTING STENTS¿. THE PATIENT HAD PRESENTED WITH ACUTE CORONARY SYNDROME. A XIENCE XPEDITION 48MM STENT WAS IMPLANTED. AROUND THE 30-DAY FOLLOW-UP, THE PATIENT EXPERIENCED A MAJOR ADVERSE CORONARY EVENT AND PRESENTED TO THE EMERGENCY DEPARTMENT IN ASYSTOLIC CARDIAC ARREST, COULD NOT BE REVIVED AND EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319831 XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death