An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Upon polymer fill of the aortic body stent graft, the polymer syringe was observed to have emptied indicating a potential intravascular leak of polymer, and the patient experienced hypotension and a seize of cardiac function requiring chest compressions.The patient was treated for a hypersensitive reaction per the ifu and was stabilized.The aneurysm was successfully excluded at the conclusion of the implant procedure.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.An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made on 06/22/2018 and were denied.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.Based on a review if the returned delivery system, there was evidence of fill polymer on the surface of the guidewire lumen and cross-over lumen, indicative that the polymer leak was in close proximity to the fill tube junction; however, this could not be definitively confirmed without a review if the intraoperative imaging.All other device components appeared intact with no evidence of a deficiency.Based on similar reported events, 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.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.A field safety notice (fs-0009) was released on (b)(6)2018 to communicate the risk of polymer leak events with the ovation device under circumstances in which the device is not used in accordance with the device instructions for use.
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