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

Recall

RC-2017-RN-00824-1

Class I

2017-06-28

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00824-1

Cook medical previously advised customers in march 2017 (rc-2017-rn-00419-1) about an update to the instructions for use (ifu) for the zenith alpha thoracic endovascular graft.Since then, cook medical has received additional complaints for the same issue. although the complaints were from patients treated prior to the march notification, there is now an additional correction of the (ifu) and the removal of specific sizes from the market.The correction to the ifu removes the indication for use in blunt thoracic aortic injury (btai), and a warning has been added to describe the thrombus risk that has been observed when the device is used to treat btai. patients already treated with this product for the btai indication should be followed up according to the current ifu, with considerations outlined in cook medical’s correspondence in march 2017.Potential adverse events that may occur if these devices were used for btai include death, paraplegia, and/or surgical intervention.

Cook Medical is requesting that Customers: 1. Share this notice with others in their organisation who either use this device or follow patients treated with this device. 2. Follow the IFU corrections as provided. 3. Examine inventory and immediately quarantine affected products. 4. Complete and return the required Acknowledgement and Receipt Form, in addition to any affected recalled products to Cook Medical. Return Goods Authorisation Number: QCR-75 Cook Medical 61 Brandl Street Eight Mile Plains QLD 4113 5. Maintain a copy of this notice for their records. Upon availability of the corrected IFU, a Cook Medical Sales Representative will personally follow-up and provide corrected IFUs for inventory.