BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2091672 · Received April 29, 2011

    Report

    Report Number
    2953200-2011-00915
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS/CONCLUSION: (AORTIC NECK CALCIFICATION AND MODERATE ANGULATION).

    Description of Event or Problem · 1

    AN ENDURANT ILIAC STENT GRAFT WAS ATTEMPTED TO BE IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.3 CM ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. THE AORTIC NECK WAS 19 MM LONG, 21.3 MM IN DIAMETER AT THE RENAL ARTERIES, WITH CALCIFICATION, THROMBUS, AND MODERATE ANGULATION. THE DELIVERY SYSTEM WAS NOT TORQUED WHEN ADVANCING OR WITHDRAWING THE TAPER TIP. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO RELEASE THE BARE SPRINGS OF THE ENDURANT BIFURCATED STENT GRAFT AND THAT THE TIP CAPTURE MECHANISM DID NOT WORK. WHILE THE PHYSICIAN WAS MODELING THE STENT GRAFT WITH A RELIANT BALLOON THE STENT GRAFT WAS SLIDING. THE PT WAS CONVERTED TO OPEN SURGERY AND IS DOING FINE. THE EXPLANTED STENT GRAFT WAS RETURNED AND ITS EVAL IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00843504

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention