Events

Safety Alert for Endurant Stent Graft System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Ireland || Medtronic 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
    R1703-83
  • Event Number
    2008DM-0002693
  • Date
    2017-03-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=99
  • 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 states that it has detected that the referenced devices may be more susceptible to presenting a variable permeability in the tissue that may be associated with the seizures observed in the initial implant procedure, during the implant procedure, this variation of the permeability may cause the surgeon to categorize a endophagetype iv (which normally resolves itself over time) as a type iii endoleak due to tissue breakage, since it may appear that the leak is localized rather than diffuse, leading to unnecessary secondary interventions, leading to the occurrence possible adverse events on the patient.

Device

Endurant Stent Graft System
  • Model / Serial
  • Product Description
    The ENDURANT endoprosthesis system is designed to treat infrarenal abdominal aortic or aortic iliac aorticilies using an endovascular technique. Once placed within the ureurysm, the enduran stent offers an alternative permanent conduit for blood flow within the vascular system of the patient, since it excludes the aneurysmal sac from blood flow and pressure.
  • Manufacturer
    Medtronic Ireland || Medtronic Inc

Manufacturer

Medtronic Ireland || Medtronic Inc
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NIDFSINVIMA