BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 4240910 · Received November 10, 2014

    Report

    Report Number
    2953200-2014-02368
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). USER ERROR CONTRIBUTED TO EVEN ( USED DAMAGED DEVICE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5+CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE WHILE PREPPING THE DEVICE A FIRST TIME NURSE PULLED UP ON BACK PORTION OF THE DEVICE WHILE PINNING THE FROM PORTION OF THE DELIVERY HANDLE (WHERE BLUE SCREW HANDLE PORTION MEETS GREY HANDLE PORTION), RESULTING IN A BRAKE OF THE SCREW DRIVE SHAFT PORTION. THE TECHNICIAN DID NOT NOTIFY THE PHYSICIAN OF THE INCIDENT AND THE DEVICE WAS LOADED ON THE WIRE AND INSERTED IN THE PATIENT. THE PHYSICIAN IDENTIFIED THE BRAKE AFTER THE DEVICE WAS INSERTED INTO THE PATIENT; HOWEVER, THE PHYSICIAN FELT COMFORTABLE THAT THE DEVICE COULD BE USED. THE DEVICE WAS USED WITHOUT ANY INJURIES TO THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY AS PLANNED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721909 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04064694

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR