Events

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

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-2017-RN-00419-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-03-29
  • 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-2017-RN-00419-1
  • 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
    The instructions for use (ifu) for the zenith alpha thoracic endovascular graft have been updated. these updates are of key importance when using the device to treat blunt thoracic aortic injury (btai), which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. there have been five reports of graft thrombosis/occlusion during global commercial use of the device, each following treatment for btai. one case resulted in patient death, and three cases resulted in reintervention. patients already treated for btai should be followed in accordance with the current ifu, since follow-up has not been amended.
  • Acción
    Cook Medical is requesting surgeons refer to the new version of the Instructions for Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft in particular to the key updates regarding the use of the device to treat blunt thoracic aortic injury (BTAI), which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. Surgeons are advised that patients already treated for BTAI should be followed in accordance with the current IFU, since follow-up has not been amended. (Please note that this recall is for information purposes. No devices need to be returned).

Device

Multiple Zenith Alpha Thoracic Endovascular Graft Products
  • Modelo / Serial
    Multiple Zenith Alpha Thoracic Endovascular Graft ProductsAll products that start with the following Catalogue Numbers:Proximal Tapered Component; ZTA-PT-Distal Component; ZTA-D-Distal Extension; ZTA-DE-Proximal Component; ZTA-P-ARTG Numbers: 222505, 222526, 222533, 222525
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd