BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENATA MINIMA STENT SYSTEM

    MDR report key: 24565249 · Received March 10, 2026

    Report

    Report Number
    3027098402-2026-00002
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 10, 2026
    Manufacturer
    RENATA MEDICAL
    Product Code
    PNF
    UDI-DI
    00196852801862
    PMA / PMN Number
    P240003
    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 STENT DID NOT FIXATE AS INTENDED DUE TO ANATOMICAL COMPLEXITIES. SURGICAL INTERVENTION WAS PERFORMED DUE TO DISTAL TRANSVERSE ARCH HYPOPLASIA. DURING THE RECONSTRUCTION OF THE AORTIC ARCH, THE MINIMA STENT WAS PARTIALLY CUT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, TWO 6MM MINIMA STENTS WERE USED TO TREAT NATIVE COARCTATION. THE INITIAL STENT MOVED FROM THE INITIAL PLACEMENT LOCATION DUE TO DIFFICULT LOCATION AND SIZING OF THE LESION. AFTER THE SECOND STENT WAS PLACED, THERE WERE NO ADVERSE EVENTS RECORDED AND THE LESION WAS TREATED. DURING FOLLOW UP, IT WAS DETERMINED THAT SURGICAL INTERVENTION WOULD BE PURSUED DUE TO PERSISTING HYPOPLASTIC TRANSVERSE ARCH. IT WAS ACKNOWLEDGED THAT THE STENT COULD BE REDILATED, BUT THE HYPOPLASTIC TRANSVERSE ARCH WOULD REQUIRE SURGERY, SO BOTH WERE ADDRESSED DURING SURGERY. ON (B)(6) 2026, THE STENT WAS PARTIALLY CUT THROUGH LONGITUDINALLY DURING A PROCEDURE TO RECONSTRUCT THE AORTIC ARCH AS WELL AS TREAT THE MEASURED GRADIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615680 RENATA MINIMA STENT SYSTEM MINIMA STENT SYSTEM PNF RENATA MEDICAL FG-0001 Z2460459C 00196852801862

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Male Other