BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENATA MINIMA STENT SYSTEM

    MDR report key: 24240777 · Received February 2, 2026

    Report

    Report Number
    3027098402-2026-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 2, 2026
    Manufacturer
    RENATA MEDICAL
    Product Code
    QWC
    UDI-DI
    00196852801862
    PMA / PMN Number
    P240003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE AND STENT INITIALLY PERFORMED AS ANTICIPATED; HOWEVER, STENT-SYSTEM INTERACTION CAUSED DISLODGEMENT AND IMPACTED THE ABILITY FOR THE STENT TO FIXATE.

    Description of Event or Problem · 0

    AN 8MM MINIMA STENT WAS USED TO TREAT A STENOSIS IN THE RIGHT PULMONARY ARTERY. THE STENT WAS DEPLOYED IN THE PROXIMAL RPA SUCH THAT IT COVERED THE OSTIUM AND OVERLAPPED INTO AN EXISTING STENT. THE FINAL STENT POSITION WAS INFLUENCED BY INTERACTION WITH INSTRUMENTATION DURING REMOVAL. THE IMPLANT WAS FIXATED IN THE SVC USING AN OFF-THE-SHELF BALLOON. AN OFF-THE-SHELF STENT WAS USED TO TREAT THE STENOSIS. NO DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302622 RENATA MINIMA STENT SYSTEM MINIMA STENT SYSTEM QWC RENATA MEDICAL FG-0002 Z2460903A 00196852801862

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Required Intervention