BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENATA MINIMA STENT SYSTEM

    MDR report key: 21574574 · Received March 11, 2025

    Report

    Report Number
    3027098402-2025-00002
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 11, 2025
    Report Date
    March 11, 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, THE UNDERLYING TISSUE CONDITION, EXISTING AVP PLUG AND SIZE OF THE VESSEL AFFECTED THE OUTCOME. THE PRESENCE AND SIZE OF THE AVP APPLIED PRESSURE TO THE STENT.

    Description of Event or Problem · 0

    ONE 6 MM MINIMA STENT WAS USED TO TREAT A LEFT PULMONARY ARTERY (LPA) STENOSIS WITH DIFFICULT UNDERLYING VESSEL CONDITIONS. AFTER THE STENT WAS PLACED, FINAL ANGIOGRAMS CONFIRMED THE STENT WAS PROPERLY LOCATED SO THE MINIMA SYSTEM AND GUIDEWIRE WERE REMOVED. FOLLOWING THE MINIMA IMPLANT, THE PHYSICIAN PROCEEDED WITH AN UNRELATED PROCEDURE, AFTER WHICH FLUOROSCOPY REVEALED THAT STENT SHIFTED TOWARDS THE MAIN PULMONARY ARTERY (MPA). THE PHYSICIAN INTERVENED AND SUCCESSFULLY REPOSITIONED THE STENT INTO THE RIGHT PULMONARY ARTERY (RPA) USING A GUIDEWIRE. THE STENT STABILIZED IN THE RPA WITHOUT A BALLOON AND THE STENOSIS WAS LEFT UNTREATED. NO DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203789 RENATA MINIMA STENT SYSTEM MINIMA STENT SYSTEM PNF RENATA MEDICAL FG-0001 Z2460459C 00196852801862

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Female Required Intervention