Events

Recall of Multiple Zenith Alpha Thoracic Endovascular Graft Products

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00419-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-03-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00419-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / 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
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd