Source: Central Alert System (CAS)
Endologix has stopped selling the Nellix EVAS device and is recalling unused stock. MHRA recommends enhanced patient surveillance due to a high risk of graft failure beyond two years after implantation.
These are the following actions that are recommended:
- Immediately stop further implants of the device.
- Identify if your centre has any device inventory that should be returned to Endologix following the instructions in the Field Safety Notice (dated 4th January, 2019).
- Identify all patients implanted with a Nellix device under surveillance at your centre.
- Notify your nearest UK expert centre (identified in the protocol in appendix 1 in the alert) with the number of patients you currently have remaining under surveillance and discuss in advance the support this centre can provide if a patient requires re-intervention.
- Continue to undertake lifelong follow-up of all patients according to normal clinical practice. Enhanced surveillance involving CT imaging should be repeated at least annually, unless the patient is considered unfit for secondary intervention. Arrange for early CT surveillance for all patients who have not received CT imaging within the last 12 months.
- The most recent scans should be compared to immediate post-operative images to identify signs of device failure. This includes significant device migration, Type I endoleak and/or aneurysm sac expansion.
- Discuss with the nearest UK expert centre all patients being considered for secondary intervention.
- Patients that are suitable for surgical explant may be treated either locally or referred on to a larger volume centre if appropriate.
- All patients in whom a Nellix-in-Nellix intervention is proposed as the optimum treatment should be treated at one of the named UK expert centres, according to the conditions set out in the protocol at appendix 1.
- Patients that are suitable for surgical explant may be treated either locally or referred on to a larger volume centre if appropriate.
Background information and problems
Affected hospitals should already have received the Field Safety Notice from Endologix, explaining that the company has stopped distributing the device and is withdrawing any unused devices from hospital inventory via a field safety corrective action (FSCA). The CE-mark (EU market authorisation) for this device is currently suspended by the Notified Body.
This MDA provides advice on steps that can be taken in the UK to identify and treat a patient with a failing Nellix implant, together with further background information.
Reason for the FSCA MHRA has considered recent evidence on the Nellix EVAS system, both published and awaiting publication, (some of which is referenced below) together with reported adverse incident data. We have identified concerns over the safety and performance of the device two years after implantation. Specifically, we have noted a high rate of graft failure due to device migration, Type 1 endoleak, or sac expansion. A number of changes have been made to the device design, indications for use and recommended implantation technique which were the subject of previous FSNs.
MHRA considers these now require robust clinical investigation to determine their effectiveness. Endologix has undertaken this voluntary FSCA to address concerns over the continued commercial use of the device. This MDA has been prepared in consultation with the MHRA’s independent expert clinical advisors and has been shared with Endologix.