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
    I1602-60
  • Event Number
    2015DM-0013350
  • Date
    2016-02-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=156
  • 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 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
  • Model / Serial
    All references
  • 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) 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.