The patient was initially implanted with an afx2 bifurcated stent graft, to treat an abdominal aortic aneurysm (aaa) in 2016 (exact date is unknown).Approximately eight (8) years post initial procedure, during a routine follow up, a type 2 (non-device related) or type 3 endoleak were suspected; however, there was no aneurysm enlargement noted.The patient is stable and currently being monitored while an intervention is being discussed.
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The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record could not be completed.The part number/lot number combination needed for device identification remains unknown.The user facility was unable to provide this information.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as being monitored.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx2.
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