Progressive Device Failure at Long Term Follow Up of the Nellix EndoVascular Aneurysm Sealing (EVAS) System

ObjectiveHigh rates of midterm failure the Nellix EndoVascular Aneurysm Sealing (EVAS) System resulted in device withdrawal from UK market. The study aim was to report long term EVAS outcomes and management a failing device.MethodsA retrospective review procedures at tertiary unit performed. Device defined as triad stent migration, separation, secondary sac expansion, or any intervention for type 1 endoleak, rupture, explant.Results161 (male n = 140, female 21) patients with median follow up 6.0 (IQR 5.0–6.6) years were included. Freedom all cause mortality estimate six 41.5%. There 70 (43.5%) failures freedom 32.3%. Failure result expansion (n 41), caudal migration 36), separation 26), AAA rupture 15). A substantial number endoleaks present (1a 33, 1b 11), but 2 endoleak rate low 3.7%. Some 36 (22.4%) required re-intervention. Twenty-one underwent explant no 30 day deaths. Six Nellix-in-Nellix application (NINA) one early death bowel ischaemia patient who died later non-aneurysm related cause. Two NINA have ongoing two had thrombosis limb visceral stent. Proximal embolisation only successful cases.ConclusionThe is high. All must be informed enrolled enhanced surveillance. an acceptable technique favourable outcomes. Management by open explant, if fit, should considered offered those failure. High device. explant. 161 cases.