BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENATA MINIMA STENT SYSTEM

    MDR report key: 21973209 · Received May 6, 2025

    Report

    Report Number
    3027098402-2025-00003
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 11, 2025
    Report Date
    May 6, 2025
    Manufacturer
    RENATA MEDICAL
    Product Code
    PNF
    UDI-DI
    00196852805037
    PMA / PMN Number
    P240003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 8 MM MINIMA STENT WAS USED TO TREAT A NATIVE AORTIC COARCTATION. AFTER THE STENT WAS PLACED, FINAL ANGIOGRAPHY INDICATED THAT THE STENT WAS PLACED IN THE TARGET LOCATION. ROUTINE POST-PROCEDURAL IMAGING IDENTIFIED THAT THE STENT MIGRATED DISTALLY THROUGH THE DESCENDING AORTA BELOW THE DIAPHRAGM. FOUR DAYS AFTER THE IMPLANT PROCEDURE, THE PATIENT UNDERWENT SURGERY TO REPAIR THE COARCTATION. DURING THE REPAIR, THE STENT WAS REMOVED. NO DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831715 RENATA MINIMA STENT SYSTEM MINIMA STENT PNF RENATA MEDICAL FG-0002 Z2460661C 00196852805037

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Female