BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMA STENT SYSTEM

    MDR report key: 20908816 · Received December 11, 2024

    Report

    Report Number
    3027098402-2024-00001
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 12, 2024
    Report Date
    November 18, 2024
    Manufacturer
    RENATA MEDICAL
    Product Code
    PNF
    UDI-DI
    00196852801862
    PMA / PMN Number
    P240003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECAUSE OF THE SIZE OF THE PATIENT, CAROTID ACCESS WAS USED TO REACH THE LESION LOCATION. ARDUOUS VASCULATURE, MEDICATION AND ACCESS LOCATION CONTRIBUTED TO DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    INITIAL PLACEMENT OF THE FIRST MINIMA STENT WAS DEPLOYED DISTAL FROM THE INTENDED DEPLOYMENT LOCATION PREVENTING THE COARCTATION FROM BEING TREATED. AN ATTEMPT TO TELESCOPE A SECOND STENT WITHIN THE FIRST STENT WAS INTENDED TO SIMULTANEOUSLY TREAT THE COARCTATION AND SECURE THE FIRST STENT IN PLACE; HOWEVER, THE SECOND STENT WAS ALSO PLACED DISTAL TO THE INTENDED LOCATION, RESULTING IN NEITHER STENT TREATING THE COARCTATION. A THIRD STENT WAS USED TO SUCCESSFULLY TREAT THE COARCTATION WITHOUT INCIDENT. AFTER COMPLETION OF THE PROCEDURE, THE TELESCOPED STENTS WERE OBSERVED TO MIGRATE DISTALLY AS A RESULT OF NOT BEING SECURED WITHIN A STENOTIC LESION. THE DAY AFTER THE PROCEDURE, X-RAYS CONFIRMED THE TELESCOPED STENTS FIXATED IN A SMALLER DIAMETER VESSEL. FOLLOWING THE IMPLANT PROCEDURE, AN UNRELATED TRANSCATHETER PROCEDURE WAS PERFORMED. DURING WHICH, THE TELESCOPED STENTS WERE RE-DILATED AS A PRECAUTIONARY MEASURE. DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141641 MINIMA STENT SYSTEM MINIMA STENT SYSTEM PNF RENATA MEDICAL FG-0001 Z2460459C 00196852801862

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male Other