Events

Notificaciones De Seguridad De Campo acerca de Zenith Alpha™

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Cook Medical Europe.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-03-22
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    With this safety announcement, we would like to remind you of several aspects of the new version of the instruction manual (nzu) for thoracic endovascular insertion of zenith alpha ™. these updates are crucial in the use of the thoracic aortic thoracic aortic disorder (tpta) device, which is now covered by the newly approved indication for individual lesions of a descending thoracic aorta. the security notice is for informational purposes only. no devices need to be returned, and patients already treated for tpta should be monitored in accordance with current nzus, as follow-up has not been altered. in a clinical trial evaluating the use of a tpta device (without occlusion, adverse clinical consequences, or the need for open surgery / bypass), an incidental thrombus was inserted in the insert during ongoing monitoring in approximately 25% of patients. the literature cites incidence insertion thrombus (including tpta treatment) in the range of 15–40% .1,2,3,4,5 occurrence of insertion occlusion (requiring open surgery / bypass) were also detected after endovascular treatment for tpta.

Device

Zenith Alpha™

Manufacturer

Cook Medical Europe