BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX FRONTIER¿

    MDR report key: 15914924 · Received December 5, 2022

    Report

    Report Number
    15914924
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 1, 2022
    Report Date
    November 14, 2022
    Manufacturer
    MEDTRONIC VASCULAR, INC.
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STENT GOT FRACTURED AND ALMOST CAME OFF THE BALLOON WHEN ATTEMPTING TO PLACE. IT WAS TO BE PLACED IN THE RCA PROXIMAL TO PREVIOUS STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472060 ONYX FRONTIER¿ CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC VASCULAR, INC. ONYXNG40015UX 0011068045

    Patients

    Seq Age Sex Outcome Treatment
    1 18615 DA Male