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
    I1611-531
  • Número del evento
    2015DM-0013350
  • Fecha
    2016-11-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=113
  • 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 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
  • Modelo / Serial
    N10-100, N10-120, N10-140, N10-160, N10-180, N10-110, N10-130, N10-150, N10-170
  • 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) 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