Nellix EndoVascular Aneurysm Sealing System 의 리콜

Recall

RC-2017-RN-01228-1

Class I

2018-01-11

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01228-1

Endologix is providing an update to the recall for product correction issued in october 2016 for the nellix system, and includes the current data available to support the refined ifu and patient selection criteria, options for secondary interventions in patients who have specific nellix related complications, and information related to off-label use of the nellix system.

Physicians are notified that all patients require life-long, regular follow-up to assess the performance of their endovascular implant. Patients with specific clinical findings (eg, changes in the structure or position of the endovascular implant, endoleaks, or enlarging aneurysms) should receive enhanced clinical and imaging follow-up. Specifically, patients should receive a contrast enhanced CT scan. If renal complications or other factors preclude the use of image contrast medium, abdominal radiographs & duplex ultrasound may provide similar information. All asymptomatic patients should continue on annual follow-up, and this is particularly important for those who would now be considered off-label according to the refined IFU. Additional secondary endovascular interventions (see below) or conversion to standard open surgical repair should be considered for patients continuing to experience migration, significant endoleaks, and/or enlarging aneurysms during post-operative follow up.