Events

Safety Alert Or Field Safety Notices for Nellix Endovascular Aneurysm Sealing (EVAS) System

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Endologix.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2019-01-25
  • Event Date Posted
    2019-01-25
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/nellix-endovascular-aneurysm-sealing-evas-system-device-recall-and-enhanced-patient-surveillance
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    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
    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.
  • Action
    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 04 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 at appendix 1) 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.

Device

Nellix Endovascular Aneurysm Sealing (EVAS) System

Manufacturer

Endologix
  • Manufacturer Address
    Endologix International Holdings B.V. Burgemeester Burgerslaan 40 5245 NH, Rosmalen, NetherlandsTel: +31 88 116 91 01customerservice@endologix.com
  • Manufacturer Parent Company (2017)
    Endologix International Holdings B.V.
  • Source
    MHRA