BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3944108 · Received July 18, 2014

    Report

    Report Number
    2953200-2014-01401
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS ATTEMPTED FOR USE IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT IN PREPARATION FOR THE PROCEDURE AND WHILE THE DELIVERY SYSTEM WAS BEING REMOVED FROM THE ORIGINAL PACKAGING A LARGE HAIR WAS IDENTIFIED ON THE DELIVERY SYSTEM. THE HAIR WAS WITHIN BOTH PEEL BACK POUCHES. THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. THE DEVICE WAS NOT INSERTED IN THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. A REVIEW OF A SINGLE RETURNED PHOTO REVEALED THAT THE DEVICE WAS PLACED WITHIN THE TRAY AND A FOREIGN MATERIAL WAS SEEN ON THE PROXIMAL PORTION OF THE TRAY IN CONTACT WITH THE DEVICE. THE OBJECT IN THE PHOTO WAS DIFFICULT TO IDENTIFY; UNABLE TO CONFIRM IF THIS WAS A HAIR. THE MATERIAL WAS THREAD-LIKE AND WAVY IN APPEARANCE AND MAY HAVE ALSO BEEN A CORRUGATED/FIBER MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422692 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03043821

    Patients

    Seq Age Sex Outcome Treatment
    1