Based on the information received, clinical evaluation confirmed the urgent presentation, type iiia endoleak, complete aortic component separation and secondary endovascular procedure.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was in stable condition post secondary endovascular procedure.A definitive root cause for the reported event could not be determined.The clinical assessment determined that there was evidence to reasonable suggest infra renal cuff dilation 40.9 mm (20%) occurred that were not included in the event as reported.The infra renal cuff dilation was discovered on (b)(6) 2018 during review of the 41 month post implant ct scan.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.The afx bifurcated stent graft indicated in describe event or problem and concomitant medical products, that had the endoleak 3a, was previously reported under mfr#2031527-2018-00220.
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An afx bifurcated stent graft system was implanted to treat an abdominal aortic aneurysm.The patient presented to the er with abdominal pain approximately 3.5 years post index procedure.A ct was performed on (b)(6) 2018, where a potential type iiia endoleak was observed.On (b)(6) 2018, the secondary procedure was performed.Reportedly, it was confirmed, there was no leak and no sac growth, just minimal overlap of the previously implanted stents.The physician elected to add a vela suprarenal cuff and a vela infrarenal cuff to improve overlap.The patient was discharged the next day and was reported to be pain free and in good condition.There have been no additional patient sequelae reported.
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