BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENATA MINIMA STENT SYSTEM

    MDR report key: 24837886 · Received April 9, 2026

    Report

    Report Number
    3027098402-2026-00004
    Event Type
    Death
    Date Received
    April 9, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 9, 2026
    Manufacturer
    RENATA MEDICAL
    Product Code
    PNF
    UDI-DI
    00196852801862
    PMA / PMN Number
    P240003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DELIVERY SYSTEM AND STENT PERFORMED AS ANTICIPATED WITH NO REPORTED MALFUNCTIONS. REVIEW OF THE CASE BY THE MEDICAL MONITOR AND INVESTIGATOR FOUND THAT THE MINIMA STENT WAS LIKELY NOT RELATED TO THE ADVERSE EVENT.

    Description of Event or Problem · 0

    THE MINIMA STENT WAS REPORTED IN A SEVERE ADVERSE EVENT DURING PATIENT PARTICIPATION IN THE MINIMA POST-APPROVAL STUDY (B)(6). A 6MM MINIMA STENT WAS USED TO TREAT AN AORTIC COARCTATION ON (B)(6) 2026. THE STENT PLACEMENT RELIEVED THE PRESSURE GRADIENT, AND ANGIOGRAM CONFIRMED A SUCCESSFUL RESULT. ON (B)(6) 2026, THE PATIENT BECAME BRADYCARDIC AND WAS PLACED ON ECMO FOLLOWING 45 MINUTES OF CPR WITHOUT RETURN OF SPONTANEOUS CIRCULATION. ON (B)(6) 2026, IMAGING REVEALED ISCHEMIC STROKE, THE PATIENT WAS DISCONTINUED FROM ECMO SUPPORT AND PRONOUNCED DECEASED. NO DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897598 RENATA MINIMA STENT SYSTEM MINIMA STENT PNF RENATA MEDICAL FG-0001 Z2460853A 00196852801862

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Male Death