Events

Retiro De Equipo (Recall) de Endologix Nellix Endovascular Aneurysm Sealing System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Endologix, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    20039
  • Fecha de inicio del evento
    2016-04-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: eVas Medical, 73 Churchill Road, Murrays Bay, Auckland 0630
  • Causa
    Updated instructions for use (ifu) for the nellix endovascular aneurysm sealing system., feature that differentiates nellix from other aaa endovascular devices is the use of a 2-part water soluble polymer that is used to fill the aneurysmal space. during the nellix procedure, polymer is dispensed through fill tubes within the catheter into endobags which surround the stent grafts. the polymer is introduced in a liquid form and begins to crosslink as soon as the components are mixed. complete crosslinking occurs inside the endobags 3 to 5 minutes after filling has been completed. the polymer will not crosslink in the fill tubes, as long as there is, continuous flow of the solution. once the polymer stops moving through the fill tubes, crosslinking can occur in 30 seconds within the fill tubes. if the polymer cures in the fill tubes, it can impede further introduction of polymer.Utilization of the secondary fill option (outline din ifu) is necessary to safely compete the filling process.
  • Acción
    Instructions for use to be updated

Device

Endologix Nellix Endovascular Aneurysm Sealing System
  • Modelo / Serial
    Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150, N10-160, N10-170,, Affected:
  • Manufacturer
    Endologix, Inc.

Manufacturer

Endologix, Inc.