BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENATA MINIMA STENT SYSTEM

    MDR report key: 22810068 · Received August 14, 2025

    Report

    Report Number
    3027098402-2025-00005
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 11, 2025
    Manufacturer
    RENATA MEDICAL
    Product Code
    PNF
    UDI-DI
    00196852801862
    PMA / PMN Number
    P240003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE AND STENT INITIALLY PERFORMED AS ANTICIPATED; HOWEVER, UNDERLYING TISSUE COMPLIANCE AND VESSEL GEOMETRY IMPACTED THE ABILITY FOR THE STENT TO FIXATE.

    Description of Event or Problem · 0

    ONE 6MM MINIMA STENT WAS USED TO TREAT AN AORTIC RE-COARCTATION. AFTER THE STENT WAS PLACED, THE PHYSICIAN ATTEMPTED TO IMPROVE FIXATION BY POST-DILATING THE STENT WITH THE SAME BALLOON. WHEN THE BALLOON WAS DEFLATED, IMAGING IDENTIFIED THAT THE STENT MIGRATED DISTALLY THROUGH THE DESCENDING AORTA SUCH THAT IT NO LONGER TREATED THE STENOSIS. A SECOND SYSTEM WAS TRACKED TO THE LESION AND AS THE BALLOON WAS EXPOSED, THE OUTER SHAFT PULLED THE FIRST IMPLANT FURTHER DISTALLY IN THE DESCENDING AORTA. THE SECOND STENT RESULTED IN SUCCESSFUL STENOSIS RELIEF AND MAINTAINED FIXATION WITHIN THE VESSEL. THE FIRST IMPLANT WAS POST-DILATED WITH AN OFF-THE-SHELF BALLOON TO PREVENT FURTHER MIGRATION. NO DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866036 RENATA MINIMA STENT SYSTEM MINIM STENT SYSTEM PNF RENATA MEDICAL FG-0001 Z2460459C 00196852801862

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DA Male Required Intervention