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
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm. Post polymer fill of the aortic body stent graft, the patient experienced hypotension and was successfully treated for an anaphylactic reaction per the device ifu. As no polymer appeared in the proximal rings, a medtronic (non-endologix) proximal stent and an addition ovation limb were implanted. The case concluded without additional negative patient sequelae and the aneurysm was excluded. The patient will continue to be monitored.
Patient Sequence No: 1, Text Type: D, B5