Events

Alerte Ou Avis De Sécurité sur Nellix Endovascular Aneurysm Sealing (EVAS) System

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Endologix.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2019-01-25
  • Date de publication de l'événement
    2019-01-25
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/nellix-endovascular-aneurysm-sealing-evas-system-device-recall-and-enhanced-patient-surveillance
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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
  • Modèle / numéro de série
  • Manufacturer
    Endologix

Manufacturer

Endologix
  • Adresse du fabricant
    Endologix International Holdings B.V. Burgemeester Burgerslaan 40 5245 NH, Rosmalen, NetherlandsTel: +31 88 116 91 01customerservice@endologix.com
  • Société-mère du fabricant (2017)
    Endologix International Holdings B.V.
  • Source
    MHRA