BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENATA MINIMA STENT SYSTEM

    MDR report key: 23317625 · Received October 16, 2025

    Report

    Report Number
    3027098402-2025-00006
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 16, 2025
    Manufacturer
    RENATA MEDICAL
    Product Code
    PNF
    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, VESSEL GEOMETRY AND IMPLANT PLACEMENT IMPACTED THE ABILITY FOR THE STENT TO FIXATE.

    Description of Event or Problem · 0

    AN 8 MM MINIMA STENT WAS USED DURING A COA PROCEDURE WITH CAROTID ACCESS. THE STENT WAS PLACED CENTRALLY ACROSS THE COA AND DEPLOYED AT THE NOMINAL PRESSURE. THE STENT MOVED DISTALLY FROM THE LESION AS THE BALLOON WAS EXTRACTED. AN OFF-THE-SHELF 9 MM BALLOON CATHETER WAS USED TO IMPROVE STENT FIXATION. THERE WAS NO ADDITIONAL INTERVENTION NEEDED FOR THE COARCTATION, AS THE STENOSIS APPEARED TO BE RELIEVED. NO DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2743924 RENATA MINIMA STENT SYSTEM MINIMA STENT SYSTEM PNF RENATA MEDICAL FG-0002 Z2460823A 00196852801862

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Female