An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The aortic body stent graft was positioned and deployed as expected.Upon polymer fill of the aortic body stent graft, the polymer syringe was observed to have emptied.Another polymer kit was mixed and attached to the delivery system; however, the second polymer syringe also emptied indicating a potential intravascular leak of polymer, and the patient experienced hypotension.The patient was treated for a hypersensitive reaction per the ifu and was stabilized.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
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The root cause for the emptying of the polymer syringe and intravascular leak of polymer could not be definitively confirmed with the information available; pre-operative and/or post-operative imaging were not available for review.The most likely cause of the emptying of the polymer syringe and intravascular leak of polymer was likely due to a compromise in the integrity of the aortic body stent graft fill channels and/or mating junction of the delivery system to the stent graft; however, this could not be definitively confirmed.It was noted that forward pressure was used to manipulate the delivery system (<90°) during polymer fill, and the crossover lumen was used pre-injection of the fill polymer which is outside the procedural steps in the device instructions for use (ifu).The delivery system was not available for evaluation and the stent graft remains implanted.As of the date of this report, there have been additional patient sequelae reported.A review of the device quality records showed that the device demonstrated compliance to established procedures and specifications at the time of manufacture.
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