| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01390-1 |
| Product Name/Description |
Nellix EndoVascular Aneurysm Sealing System
ARTG Numbers: 234418 , 235301, 271832, 271833 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
The pre-market clinical trials & post-market surveillance data showed that the rates for device migration, endoleak, and/or aneurysm enlargement were higher than anticipated. A root cause investigation, including consultation with physicians and review of CT scans of patients with the events was completed. Based upon this, Endologix is updating the Instructions for Use (IFU) with more detailed information regarding the indications for use, patient selection criteria & procedural best practices.
Furthermore, patients exhibiting the following key anatomic elements may be at risk regardless of the Nellix System version being implanted:
· Anatomies outside of the respective, specific criteria defined as part of the indications for use
· Narrow aortoiliac bifurcation not suitable for balloon-expandable stent deployment
· Formation of thrombus &/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface (i.e., sealing zone). |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
The outcome of the investigation resulted in the refined indication for use, patient selection criteria, and procedural best practices as outlined in the customer letter. Endologix representative will provide additional training on the key IFU changes to enable Physicians and their team to become familiar with the updated IFU prior to formal availability.
Physicians are notified that all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular implant. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular implant) should receive enhanced follow-up. Additional endovascular intervention or conversion to standard open surgical repair should be considered for patients continuing to experience enlarging aneurysms, implant displacement, and/or significant endoleaks during post-operative follow up. This action has been closed-out on 17/05/2017. |
| Contact Information |
02 8874 3100 - Getinge Group |