BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 11324733 · Received February 12, 2021

    Report

    Report Number
    2024168-2021-01175
    Event Type
    Death
    Date Received
    February 12, 2021
    Date of Event
    March 29, 2017
    Report Date
    February 12, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH, EVENT, TESTS, THERAPY, AND IMPLANT: DATE IS ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED 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. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. ARTICLE TITLED GEOGRAPHICAL DIFFERENCE OF THE INTERACTION OF SEX WITH TREATMENT STRATEGY IN PATIENTS WITH MULTIVESSEL DISEASE AND LEFT MAIN DISEASE."

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE DRUG-ELUTING STENTS THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, STROKE, REVASCULARIZATION, AND DEATH. DETAILS ARE LISTED IN THE ARTICLE, TITLED GEOGRAPHICAL DIFFERENCE OF THE INTERACTION OF SEX WITH TREATMENT STRATEGY IN PATIENTS WITH MULTIVESSEL DISEASE AND LEFT MAIN DISEASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217557 XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death