Events

Safety Alert for endovascular medical device - Nellix stent

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Endologix Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1611-531
  • Event Number
    2015DM-0013350
  • Date
    2016-11-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=113
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    N10-100, N10-120, N10-140, N10-160, N10-180, N10-110, N10-130, N10-150, N10-170
  • Product Description
    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