BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENATA MINIMIA STENT SYSTEM

    MDR report key: 21389621 · Received February 14, 2025

    Report

    Report Number
    3027098402-2025-00001
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 16, 2025
    Report Date
    February 4, 2025
    Manufacturer
    RENATA MEDICAL
    Product Code
    PNF
    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 AND SIZE OF THE VESSEL AFFECTED THE OUTCOME.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED WITH THREE, TELESCOPED 6 MM MINIMA STENTS COVERING A 32-MM-LONG STENOSIS IN THE RPA. POST-PROCEDURE X-RAYS SHOWED THAT THE PROXIMAL STENT IN THE SERIES WAS 5 MM MORE PROXIMAL TOWARDS THE MPA THAN THE INITIAL IMPLANT POSITION. A FOURTH STENT WAS SUCCESSFULLY PLACED TO COMPLETELY RELIEVE THE STENOSIS. NO DEVICES WERE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126556 RENATA MINIMIA STENT SYSTEM MINIMA STENT PNF RENATA MEDICAL FG-0001 Z2460459C

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Female Required Intervention