A review of the manufacturing lot confirmed all devices met specifications prior to release.The explanted devices will not be returned and no evaluation will be completed.Based on the information received at the completion of the clinical evaluation, there were reported evidence that supported the following case event.Clinical was able to confirm the surgical conversion performed on (b)(6) 2017 and in addition, noted stent buckling (95%) and a type 3b on the upper most suprarenal cuff.Clinical also noted the main body stent had a dilation of the superior stent margin of the bifurcated stent (28%) with a type 3b endoleak at the bifurcation with stent buckling (reference 2031527-2018-00026), and on the lower suprarenal cuff, a crown separation, a type 3b endoleak with 169% dilation, multiple stent fractures of the cage, and a type 3a endoleak with complete implant separation (will be referenced in a separate report).The most likely cause of the compromised stent graft integrity of both cuffs and the main body stent was the use of strata material.The most likely cause of the multiple stent fractures and crown separation of the lower cuff could not be identified due to lack of medical imaging surrounding the event.However the complete component separation and severe buckling of the upper most cuff and main body stent was likely a result of an elongated rendering of treatment, reportedly, ~ 1.5 to 2.0 years from the onset of a non descriptive device issue.Reportedly, the patient was doing well post explant; there have been no reports of further negative patient sequelae.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b 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 3b 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 3b endoleak events reported for afx devices has been reduced to <0.2%.These types of events will be monitored and trended as part of the quality system.
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