Events

Safety Alert for Zenith endovascular graft

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

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
    I1704-147
  • Event Number
    2010DM-0006008
  • Date
    2017-04-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=92
  • 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 new instructions for use (ifu) have been approved with updated information, changes to the ifu are of key importance when using the device for the treatment of thoracic aortic lesions (btai), which is now covered by the indication recently approved for lesions insulated from the descending thoracic aorta, this in order to seminimize and prevent adverse events on patients.

Device

Zenith endovascular graft
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Used in the minimally invasive treatment of pathologies of the thoracic aorta, the ZENITH ALPHA thoracic stent is indicated for the treatment of patients with lesions isolated from the descending aortathoracic (excluding dissections), whose vascular anatomical configuration is suitable for endovascular repair, including: anatomical iliac / femorala adequate for access with the required introduction systems non-aneurysmal aortic segments (fixation sites) proximal and distal with respect to the thoracic lesion: with a minimum length of 20mm, and with a mean external wall diameter exterior wall not exceeding 42mm and not less than 15mm.
  • Manufacturer
    William Cook Europe Aps

Manufacturer

William Cook Europe Aps