BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2231145 · Received August 26, 2011

    Report

    Report Number
    2953200-2011-01481
    Event Type
    Injury
    Date Received
    August 26, 2011
    Report Date
    July 29, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: GRAFT OCCLUSION. TIGHT AORTIC BIFURCATION; CALCIFIED ILIAC ARTERIES. CONCLUSION: TIGHT AORTIC BIFURCATION; CALCIFIED ILIAC ARTERIES.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNK SIZE APPROXIMATELY 22 MONTHS AGO. THE AORTIC BIFURCATION WAS TIGHT, AND THE ILIAC ARTERIES WERE CALCIFIED. IT WAS REPORTED THAT THE 1 MONTH CT SCAN SHOWED THAT THE STENT GRAFT HAD LOST PATENCY IN THE RIGHT ILIAC/IPSILATERAL LIMB AND BECAME OCCLUDED. THE POST-PROCEDURE CT SCAN CONFIRMED THAT THE BIFURCATION WAS TIGHT. ON AN UNK DATE, THE PHYSICIAN ELECTED TO PERFORM A FEMORAL-FEMORAL BYPASS, WHICH SUCCESSFULLY RESOLVED THE OCCLUSION. NO ADDITIONAL 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 CARDIOVASCULAR IRELAND NA V00345475

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention