Events

Rappel de Endologix Nellix Endovascular Aneurysm Sealing System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Endologix, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    20039
  • Date de mise en oeuvre de l'événement
    2016-04-19
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: eVas Medical, 73 Churchill Road, Murrays Bay, Auckland 0630
  • Cause
    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.
  • Action
    Instructions for use to be updated

Device

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

Manufacturer

Endologix, Inc.