BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX FRONTIER¿

    MDR report key: 25276842 · Received May 26, 2026

    Report

    Report Number
    25276842
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 14, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONYX STENT - STENT STRUTS WERE BENT. SITE CONTACT EMAILED THE VENDOR. MANUFACTURER RESPONSE FOR VASCULAR STENT, ONYX STENT (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407786 ONYX FRONTIER¿ CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC, INC. ONYXNG22530UX 12195729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other