BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC PERIPHERAL (FORMERLY COVIDIEN VASCULAR / EV3)

    MDR report key: 15410369 · Received September 13, 2022

    Report

    Report Number
    15410369
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 17, 2022
    Report Date
    August 30, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING THE COURSE OF A RENAL STENTING IN INTERVENTIONAL RADIOGRAPHY, THE STENT BECAME DISLODGED FROM THE DEVICE USED TO PLACE IT AND WAS LEFT INSIDE THE PATIENT'S AORTA INSTEAD OF THE RENAL ARTERY IT WAS INTENDED TO BE IN. MULTIPLE TECHNIQUES AND ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE THAT ULTIMATELY WERE UNSUCCESSFUL. THE VASCULAR SURGEON WAS ABLE TO MOVE THE LOOSE STENT FROM THE AORTA AND ULTIMATELY LEFT IT IN THE LEFT HYPOGASTRIC ARTERY BUT WAS UNABLE TO REMOVE IT FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580998 MEDTRONIC PERIPHERAL (FORMERLY COVIDIEN VASCULAR / EV3) STENT, ILIAC NIO MEDTRONIC, INC. PXB35-06-17-080 B372128

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Male