BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3092600 · Received May 3, 2013

    Report

    Report Number
    2953200-2013-00825
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: REMOVAL DIFFICULTIES. NOSECONE RETRACTED INTO OUTER SHEATH. CONCLUSION: NOSECONE RETRACTED INTO OUTER SHEATH. REMOVAL DIFFICULTIES.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS UNREMARKABLE. THE DELIVERY SYSTEM WAS DISCARDED. IT WAS REPORTED THAT AFTER THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED THE PHYSICIAN FORGOT TO RETRACT THE NOSECONE INTO THE OUTER SHEATH PRIOR TO DELIVERY SYSTEM REMOVAL. AFTER THIS WAS REALIZED THE PHYSICIAN RETRACTED THE NOSECONE INTO THE OUTER SHEATH AND SUCCESSFULLY REMOVED THE DELIVERY SYSTEM. THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT IS FINE. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194683 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01727491

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR