The device involved in this event will not be returned for evaluation as it remains implanted in the patient. Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist. If additional information pertinent to the incident is obtained, a follow-up report will be submitted. Device iteration is afx with duraply.
Patient Sequence No: 1, Text Type: N, H10
The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extensions and an ovation ix extender stent graft extension to treat an abdominal aortic aneurysm. This initial procedure is outside the indications of use due to the use of adjunctive devices not compatible with afx system per the ifu. Approximately 2 years post initial implant, dilation and movement of the proximal extension (suprarenal stent graft) was reported. An intervention was completed. The physician elected to implant another suprarenal stent graft extension to treat this event. The patient is doing well.
Patient Sequence No: 1, Text Type: D, B5