Events

Alerte De Sécurité sur endovascular medical device - Nellix stent

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Endologix Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1611-531
  • Numéro de l'événement
    2015DM-0013350
  • Date
    2016-11-24
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=113
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer reports that it has detected that the frequency of displacement of the implants, of endoleaks or the size of the aneurysm has been higher than expected, therefore, it has decided to update the instructions of use with more detailed information of the indications of use, selection criteria of the patient and optimal practices for the intervention, avoiding that its misuse leads to the occurrence of potentially adverse events on patients.

Device

endovascular medical device - Nellix stent
  • Modèle / numéro de série
    N10-100, N10-120, N10-140, N10-160, N10-180, N10-110, N10-130, N10-150, N10-170
  • Description du dispositif
    The abdominal aortic endograft "NELLIX ENDO VASCULAR ANEURYSM SEALING SYSTEM" (endo vascular system for infrarenal aortic aneurysm NELLIX) consists of a cobalt chromium stent, expandable balloon covered with PTFE (high density polytetrafluoroethylene expanded) and a bag (called endobag) The NELLIX ENDO VASCULAR ANEURYSMSEALING SYSTEM (NELLIX infrarenal aneurysm system) is indicated for the treatment of infrarenal abdominal aortic aneurysm NELLIX System Removal is performed by introducing two stent, each one with a reinforced polyester sheath. Through each femoral artery using a "catheter-based" delivery system, after implantation of both NELLIX stents crossing the aneurysm, the stents are expanded by balloon and then a polymer is injected into the bags that cover the stents in order to fill the space of the aneu blood lumen risma out of the losstents, thus excluding and sealing the aneurysm. The use of "NELLIX ENDO VASCULAR ANEURYSM SEALINGSYSTEM" (system with endovascular seal for infrarenal aortic aneurysm NELLIX) is exclusive for usopor trained professionals and qualified institutions.
  • Manufacturer
    Endologix Inc

Manufacturer

Endologix Inc