BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX FRONTIER¿

    MDR report key: 16137221 · Received January 11, 2023

    Report

    Report Number
    16137221
    Event Type
    Death
    Date Received
    January 11, 2023
    Date of Event
    December 22, 2022
    Report Date
    December 27, 2022
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ELUTING STENT DURING CARDIAC CATHETER GOT STUCK IN THE VESSEL AND BROKE IN HALF WHILE ATTEMPTING TO PULL THE STENT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419167 ONYX FRONTIER¿ CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC VASCULAR 0011039027

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death