Events

Retiro De Equipo (Recall) de Zenith Alpha Thoracic Endovascular Graft

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00101-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00101-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Cook medical is informing their customers that additional warnings and precautions are being implemented in the instructions for use (ifu) for the zenith alpha thoracic endovascular graft. the updates to the ifu are being made to emphasise best practices in response to a few recent findings of distal type i endoleak, migration and aneurysm growth during on-going longer-term follow-up of patients enrolled in the multi-national clinical investigation of the device.
  • Acción
    Cook Medical is notifying surgeons and hospitals of the updated information in the package insert. Surgeons are advised that patients already implanted with the device should receive additional surveillance and treatment where required. Further information can be found on the TGA web site at https://www.tga.gov.au/alert/zenith-alpha-thoracic-endovascular-graft. This action has been closed-out on 15/02/2017.

Device

Zenith Alpha Thoracic Endovascular Graft

Manufacturer

William A Cook Australia Pty Ltd