At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; rupture, explant, and pain.Clinical evaluations was unable to find substantial evidence to support the following reported events; endoleak type iiib.Additionally there was evidence to reasonably support the following observations; aneurysm sac growth, endoleak type iiia with partial separation, dilation of superior stent margin of main body stent by 20%, collapse of main body with ~20% narrowing, congestive heart failure, and pulmonary emboli.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 loss of seal could not be determined, however the subsequent remodeling of the aorta and 68 degree infrarenal angulation likely contributed to the partial separation of the main body and proximal extension.Additionally, the aortic remodeling likely contributed to a partial collapse of the main body stent.Unable to determine procedure-related or user-related issues, and cautionary or off-label product use conditions.Procedure-related harms include: congestive heart failure and pulmonary emboli.Associated clinical harms for this device malfunction included: aneurysm sac growth; pain; rupture; endoleak iiia, surgical conversion.The most likely cause of compromise stent graft integrity could not be determined.However, the movement of suprarenal cuff relative to the main body with the aneurysm remodeling likely contributed to this event and dilation of the proximal main body stent.Unable to determine procedure-related or user-related issues, and cautionary or off-label product use conditions.Associated clinical harms for this device malfunction included: endoleak iiib.Final patient disposition was reported as no further negative patient sequelae.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiia endoleak.The root causes have been identified as; patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; patient conditions including disease progression or anatomical changes post implant; off label product use including patient anatomy, overlap length, oversizing between components, and placement of the devices within the anatomy of the patient.Endologix implemented the following corrective actions to reduce the type iiia endoleak events; sizing guidance and instructions were updated in the ifu and released on 06/17/2015, field training was completed by 08/03/2015.Since the corrective actions were implemented the type iiia events have been reduced significantly and are well within the acceptable range per our risk assessment.Root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3a endoleak.The root causes have been identified as; patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; patient conditions including disease progression or anatomical changes post implant; off label product use including patient anatomy, overlap length, oversizing between components, and placement of the devices within the anatomy of the patient.Endologix implemented the following corrective actions to reduce the type 3a endoleak events; sizing guidance and instructions were updated in the ifu and released on 06/17/2015, field training was completed by 08/03/2015.Since the corrective actions were implemented the type 3a events have been reduced by 95%.The review of manufacturing lot confirmed all devices met specifications prior to release.Device was not returned, therefore, sample evaluation was not completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
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