Events

Alerta De Seguridad O Notificaciones De Seguridad para Nellix Endovascular Aneurysm Sealing (EVAS) System

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Endologix.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Fecha
    2019-01-25
  • Fecha de publicación del evento
    2019-01-25
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/nellix-endovascular-aneurysm-sealing-evas-system-device-recall-and-enhanced-patient-surveillance
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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
  • Dirección del fabricante
    Endologix International Holdings B.V. Burgemeester Burgerslaan 40 5245 NH, Rosmalen, NetherlandsTel: +31 88 116 91 01customerservice@endologix.com
  • Empresa matriz del fabricante (2017)
    Endologix International Holdings B.V.
  • Source
    MHRA