BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3771483 · Received April 24, 2014

    Report

    Report Number
    2953200-2014-00835
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 30, 2014
    Report Date
    March 30, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CONCLUSION: FAILURE TO FOLLOW INSTRUCTIONS (DEFECT NOTED PRIOR TO USE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE AND WHILE PREPPING THE DELIVERY SYSTEM, THE PHYSICIAN FLUSHED THE DEVICE WITHOUT ISSUES. AFTER CONFIRMATION OF THE MARKER POSITIONING AND WHILE PASSING THE DELIVERY SYSTEM THROUGH THE GUIDE WIRE THE PHYSICIAN NOTED THE REAR HANDLE COMING OFF. THE PHYSICIAN RE-SEATED THE HANDLE BY HAND AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ISSUES WERE NOTED DURING STENT GRAFT DEPLOYMENT AND NO VISIBLE DAMAGE WAS VISIBLE TO THE DEVICE OR PACKAGING. NO ISSUES WERE NOTED DURING REMOVAL OF THE DELIVERY SYSTEM AND THERE WERE NO INJURIES TO THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249288 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04181655

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR