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
    I1602-60
  • Numéro de l'événement
    2015DM-0013350
  • Date
    2016-02-17
  • 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=156
  • 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 informs that it will carry out an update and modification of its instructions for use, which should be made known to the medical personnel who use this technology, avoiding that its misuse leads to the occurrence of potentially adverse events on the patients.

Device

endovascular medical device - Nellix stent
  • Modèle / numéro de série
    All references
  • 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) Take it around with reinforced polyester sheath. Abdominal aortic stent graft "NELLIX ENDO VASCULARANEURYSM SEALING SYSTEM" (system with endovascular seal for infrarenal aneurysm NELLIX) is indicated for the treatment of abdominal-abdominal aortic aneurysm. The NELLIX system implant is performed by introducing two stents, each through each femoral artery using a "based" delivery system. After the implantation of both NELLIX stent cross-over the aneurysm, the stents are expanded by means of a balloon and then a polymer is injected into the lining bags, in order to fill the aneurysm lumensanguineous space outside the stents, thus excluding the aneurysm . The use of "NELLIXENDO VASCULAR ANEURYSM SEALING SYSTEM" (system with endo vascular seal for NELLIX infrarrenal aortic aneurysm) is exclusive for use by trained professionals and qualified institutions.
  • Manufacturer
    Endologix Inc.

Manufacturer

Endologix Inc.