BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENATA MINIMA STENT SYSTEM

    MDR report key: 24683215 · Received March 24, 2026

    Report

    Report Number
    3027098402-2026-00003
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 23, 2026
    Manufacturer
    RENATA MEDICAL
    Product Code
    PNF
    UDI-DI
    00196852801862
    PMA / PMN Number
    P240003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE AND STENT INITIALLY PERFORMED AS ANTICIPATED; HOWEVER, OFF-LABEL PRE-PROCEDURAL MODIFICATIONS (REMOVING THE STENT FROM THE BALLOON) AND VESSEL SIZING LARGER THAN MINIMA STENT LABELED SIZING HAVE POTENTIALLY IMPACTED THE ABILITY OF THE STENT TO BE DEPLOYED IN THE INTENDED LOCATION AND PROPERLY FIXATE.

    Description of Event or Problem · 0

    AN 8MM MINIMA STENT WAS USED IN A PROCEDURE TO TREAT A NATIVE COARCTATION IN A VESSEL LARGER THAN THE STENT'S LABELED IMPLANTABLE RANGE. PRIOR TO THE PROCEDURE, THE PHYSICIAN REMOVED THE STENT FROM THE BALLOON TO MODIFY THE STENT. WHEN DEPLOYED, THE STENT MISSED THE TARGET LOCATION. THOUGH THE STENT WAS STABLE AT THE END OF THE PROCEDURE, AN X-RAY LATER IDENTIFIED THE STENT HAD MOVED FROM THE DEPLOYMENT LOCATION INTO THE BRACHIOCEPHALIC ARTERY. A FOLLOW-UP PROCEDURE WAS PERFORMED TWO DAYS LATER TO PLACE AN ADDITIONAL 8MM MINIMA STENT IN THE STENOSIS AND FURTHER FIXATE THE FIRST STENT. NO DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743593 RENATA MINIMA STENT SYSTEM MINIMA STENT SYSTEM PNF RENATA MEDICAL FG-0002 Z2460949A 00196852801862

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Required Intervention