BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3853433 · Received June 6, 2014

    Report

    Report Number
    2953200-2014-01136
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 72.7 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED TO BE MODERATELY TORTUOUS. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO IMPLANT THE STENT GRAFT. AS THE PHYSICIAN STARTED TO DEPLOY TIP CAPTURE MECHANISM, IT WAS NOTICED THAT THE BACK END WHEEL WAS BROKEN AT THE TOP OF THE SCREW GEAR. THE WHEEL WAS SEEN TO BE SNAPPED COMPLETELY IN TWO. THE DEPLOYMENT WAS AT A CRITICAL STAGE AND PAST THE POINT OF NO RETURN, SO THE PHYSICIAN HELD THE TWO PIECES TOGETHER AND WAS ABLE TO SUCCESSFULLY DEPLOY THE TIP CAPTURE. THE IPSILATERAL LEG WAS THEN DEPLOYED AND THE TIP RECAPTURED. THE DELIVERY DEVICE WAS REMOVED FROM THE PATIENT WITHOUT FURTHER INCIDENT. TWO MORE STENT GRAFTS WERE SUBSEQUENTLY DEPLOYED WITHOUT ISSUE. THE DEVICE SHOWED NO SIGNS OF BEING BROKEN WHEN REMOVED FROM THE PACKAGED AND FLUSHED PRIOR TO USE. THE WHEEL FRACTURE ONLY BECAME EVIDENT WHEN THE PHYSICIAN BEGAN TO TURN THE WHEEL. THE INNER ORANGE BOX FOR THE DELIVERY SYSTEM WAS LATER EXAMINED, AND IT WAS SEEN TO BE CREASED IN THE AREA CORRESPONDING TO THE DELIVERY SYSTEM DAMAGE. THE OUTER CARDBOARD BOX, WHICH HAD HELD TWO DELIVERY SYSTEMS, WAS APPARENTLY TOO SHORT, AND HAD BEEN LENGTHENED BY EXTENDING THE END FLAPS OUT AND TAPING TOGETHER OVER THE ENDS OF THE INNER ORANGE BOXES. THERE WAS NO BUBBLE WRAP OR OTHER PACKING MATERIAL TO SUPPORT THE DELIVERY SYSTEM BOXES. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331843 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04185358

    Patients

    Seq Age Sex Outcome Treatment
    1