Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.It was confirmed that patient had a stent fracture of the main body at bifurcation, a endoleak type 3b, and an aneurysm enlargement.A secondary procedure was done to resolve issue with a reline of a non-endologix graft.At 31 months post implant, patient was noted for pain.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent graft integrity was related to the protruding stent strut of the main body near the aortic bifurcation.The most likely cause of the stent fracture could not be determined, however, the 72 degree angulation of the left common iliac artery (cautionary product use condition) likely contributed to the event.The final patient disposition was discharged post operative day two in stable condition.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.The type iiib endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at (b)(4)%.Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to <0.2%.In addition, the review of manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.
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