Events

Alerta De Seguridad para endovascular medical device - Nellix stent

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Endologix Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1602-60
  • Número del evento
    2015DM-0013350
  • Fecha
    2016-02-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=156
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    All references
  • Descripción del producto
    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.