Events

Alerta De Seguridad para Zenith endovascular graft

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 William Cook Europe Aps.

¿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
    I1704-147
  • Número del evento
    2010DM-0006008
  • Fecha
    2017-04-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=92
  • 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 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
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    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