Objective Endovascular aneurysm repair can be performed using multiple commercially available stent graft systems, each with their own unique design features and potential complications. This study evaluated the incidence, risk factors and outcomes of patients who developed an anaphylactic reaction following systemic exposure to the polymer used with the Ovation Abdominal Stent Graft System (Endologix Inc., Irvine, CA). Methods We reviewed all reports related to polymer leak with the device received by the manufacturer (formerly known as TriVascular, Santa Rosa, CA). Patients who developed an anaphylactic or hypersensitivity reaction were evaluated for root cause. The manufacturer was contacted to assemble all available data and outcomes related to the case reports. Results Between November 2009 and August 2016, polymer leak was reported in 26 patients (mean age, 77, range 61–100 years) from approximately 10,000 device implants (reported incidence, 0.26%). Symptoms occurred in 24 patients, with hypotension being the primary symptom. Treatment was in accordance for an anaphylactic reaction. There were no deaths, and the aneurysm sac remained unexcluded in three patients at the end of the case. Of these, one patient underwent successful endovascular re-intervention, one was converted to open surgical repair and one patient continued to be monitored. Factors that appear to contribute to the risk of polymer leak include initial manufacturing process for the device, excessive graft manipulation, early ballooning prior to complete polymer cure and lower body temperature, which can slow the polymer cure rate. Conclusion Although polymer leak and anaphylaxis appear to be an infrequent event associated with use of the Ovation graft, awareness of this complication and prompt recognition can allow for timely treatment. Returning the patient to hemodynamic stability can allow for completion of the procedure and successful exclusion of the aneurysm sac.

No abstract

Objectives: Endovascular aneurysm repair can be performed using multiple commercially available stent graft systems, each with their own unique design features and potential complications. This study evaluated the incidence, potential causative factors and outcomes of patients that developed an anaphylactic reaction following systemic exposure to the polyethylene glycol-based polymer used with the Ovation Abdominal Stent Graft System (Trivascular, Santa Rosa, Calif).Methods: We reviewed all reports related to polymer leak with the Ovation device received by the manufacturer. Patients that developed an anaphylactic or hypersensitivity reaction were evaluated for root cause. We independently analyzed the assembled data and outcomes.Results: Between September 2010 through August 2016, polymer leak was reported in 26 patients (mean age, 77 years; range, 61-100 years) among approximately 10,000 device implants (reported incidence, 0.26%). Symptoms occurred in 24 patients, with hypotension being the primary symptom. Treatment was in accordance with an anaphylactic reaction. There were three (11.5%) type 1 endoleaks. Of these, one patient underwent successful endovascular reintervention, one was converted to open surgical repair and one patient continues to be monitored. Factors that seem to contribute to the risk of polymer leak include manufacturing process, excessive graft manipulation, early ballooning before complete polymer cure, and lower body temperature, which can slow the polymer cure rate.Conclusions: Although polymer leak and anaphylaxis seems to be an infrequent event associated with use of the Ovation graft, awareness of this complication and prompt recognition can allow for timely treatment. Returning the patient to hemodynamic stability can allow for completion of the procedure and successful exclusion of the aneurysm sac.