BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO PLUG SET

    MDR report key: 24901269 · Received April 16, 2026

    Report

    Report Number
    3012276280-2026-00001
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    November 18, 2025
    Report Date
    April 16, 2026
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KRD
    UDI-DI
    00867966000112
    PMA / PMN Number
    K182944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS IDENTIFIED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. UPON REVIEW, THE MANUFACTURER DETERMINED THE EVENT MEETS FDA CRITERIA FOR REPORTING. THE REPORT IS BEING SUBMITTED TO ENSURE ACCURACY AND COMPLETENESS OF MDR FILES. THIS SUBMISSION DOES NOT REFLECT A CHANGE IN DEVICE PERFORMANCE OR PATIENT RISK. THE AWARENESS DATE CORRESPONDS TO WHEN THE MANUFACTURER BECAME AWARE OF THE EVENT DETAILS. ALL INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THIS TIME HAS BEEN INCLUDED. THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT WHEN ATTEMPTING TO CLOSE THE PATENT DUCTUS ARTERIOSUS (PDA) WITH A 5 MILLIMETER DEVICE, IT SEEMED OVERSIZED AND WAS RECAPTURED AND REPLACED WITH A 4 MILLIMETER DEVICE. LATER FOLLOW-UP IMAGING SHOWED A GRADIENT WAS IN THE AORTA. THE DECISION WAS MADE TO SURGICALLY REMOVE THE DEVICE. THE PATIENT IS DOING FINE. NO ADDITIONAL DETAILS WERE PROVIDED. PER DR. (B)(6): LATE AORTIC PROTRUSION REQUIRING REMOVAL OF THE DEVICE SURGICALLY. DEVICE WAS IMPLANTED BY DR. (B)(6). BASED ON A BRIEF CONVERSATION WITH DR. (B)(6) ON 2/16/24, DR. (B)(6) WAS USING THE MICRO PLUG SET TO TREAT A PATIENT WITH PDA. HE INITIALLY ATTEMPTED TO CLOSE THE PDA WITH A 5 MM (KA90002) DEVICE - IT SEEMED OVERSIZED AND WAS RECAPTURED AND REPLACED WITH A 4 MM (KA90001) DEVICE. AT LATER FOLLOW-UP IMAGING, A GRADIENT WAS NOTED IN THE AORTA. THE DECISION WAS MADE TO SURGICALLY REMOVE THE DEVICE. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966068 MICRO PLUG SET DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MERIT MEDICAL SYSTEMS, INC. 202882 00867966000112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention