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.
Patient Sequence No: 1, Text Type: N, H10
The patient was initially implanted with a bifurcated stent graft and an infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa). Approximately 9. 5 years post initial procedure, a type 3a endoleak and thrombus in the abdominal aneurysm was identified. The patient has claudication in his hips and buttocks and three vessel coronary disease, the patient is currently receiving coronary artery bypass grafting (cabg) treatment and the abdominal aneurysm has shrunk in size.
Patient Sequence No: 1, Text Type: D, B5