BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT IIS

    MDR report key: 4792335 · Received May 22, 2015

    Report

    Report Number
    2953200-2015-00936
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 27, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR USE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE BIFURCATION STENT GRAFT WAS DEPLOYED PROPERLY AND DURING REMOVAL OF THE DELIVERY SYSTEM THE DELIVERY SYSTEM WAS NEARLY OUT OF THE PATIENT WHEN THE BACK END GRAY PART OF END OF SYSTEM UNSCREWED APART. THE PHYSICIAN NOTICED THAT IT CAME UNSCREWED AND SCREWED IT BACK TOGETHER AND FURTHER REMOVAL OVER THE WIRE OUTSIDE OF THE PATIENT WAS COMPLETED WITHOUT ANY PROBLEMS. NO PATIENT COMPLICATION DURING DEPLOYMENT ONLY WITH REMOVAL OF DELIVERY SYSTEM WAS ENCOUNTERED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE PHYSICIAN STATED THE EVENT WAS RELATED TO THE DEVICE EVALUATION SUMMARY: THE EVENT WAS CONFIRMED; THE REAR HANDLE COULD EASILY BE SEPARATED FROM THE DELIVERY SYSTEM. THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY MANUFACTURING RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337124 ENDURANT IIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V06068316

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR