BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2080582 · Received April 22, 2011

    Report

    Report Number
    2953200-2011-00856
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ARTERIAL OCCLUSION). RESULTS & CONCLUSION: (INADVERTENT MOVEMENT OF THE C-ARM DURING DEPLOYMENT OF THE STENT GRAFT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. IT WAS REPORTED THAT THE C-ARM PICTURE WAS MARKED ON THE SCREEN; HOWEVER, AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED, IT WAS NOTICED THAT THE C-ARM INADVERTENTLY MOVED AND THE STENT GRAFT WAS INACCURATELY DEPLOYED AND PARTIALLY COVERED A RENAL ARTERY. THE RENAL ARTERY REMAINS PATENT/OPEN AT THIS TIME AND THE PT WAS KEPT ON HEPARIN OVER NIGHT. THE FOLLOWING DAY, THE PHYSICIAN IMPLANTED A RENAL STENT IN THE CATHETER LAB WHERE BETTER IMAGING AND MORE APPROPRIATE EQUIPMENT CAN BE UTILIZED, TO ENSURE LONG TERM PATENCY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00841945

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention