William Cook Europe has issued a medical device safety alert concerning its Zenith Alpha Thoracic Endovascular Graft (ZTA-). [Catalog numbers: ZTA-D-28-160, ZTA-D-28-229, ZTA-D-30-160, ZTA-D-30-229, ZTA-D-32-160, ZTA-D-32-229, ZTA-D-34-142, ZTA-D-34-190, ZTA-D-36-142, ZTA-D-36-190, ZTA-D-38-147, ZTA-D-38-197, ZTA-D-40-147, ZTA-D-40-197, ZTA-D-42-152, ZTA-D-42-204, ZTA-D-44-157, ZTA-D-44-211, ZTA-D-46-157, ZTA-D-46-211, ZTA-DE-18-104, ZTA-DE-18-148, ZTA-DE-20-104, ZTA-DE-20-148, ZTA-DE-22-104, ZTA-DE-22-148, ZTA-DE-24-104, ZTA-DE-24-148, ZTA-DE-26-104, ZTA-DE-26-148, ZTA-DE-28-108, ZTA-DE-28-154, ZTA-DE-30-108, ZTA-DE-30-154, ZTA-DE-32-108, ZTA-DE-32-154, ZTA-DE-34-112, ZTA-DE-34-160, ZTA-DE-36-112, ZTA-DE-36-160, ZTA-DE-38-141, ZTA-DE-38-91, ZTA-DE-40,-141 ZTA-DE-40-91, ZTA-DE-42-146, ZTA-DE-42-94, ZTA-DE-44-151, ZTA-DE-44-97, ZTA-DE-46-151]
The safety communication is to call the attention to several aspects of the new version of the Instructions for Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft. The updates are of key importance when using the device to treat blunt thoracic aortic injury (BTAI), which is covered under the newly approved indication for isolated lesions of the descending thoracic aorta.
The clinical trial patients with thrombus tended to have smaller graft diameters and greater oversizing on average than the patients without thrombus. Similar trends were observed among the commercial reports as well, with those patients also tending to have a small aortic arch radius of curvature. Additionally, while approximately 50% of the clinical trial patients had an aortic diameter that tapered from large proximally to small distally (by at least 10%), a tapered graft was not consistently used (20% received a tapered graft).
According to the manufacturer, the Field Safety Notice is for information purposes. No devices need to be returned, and patients already treated for BTAI should be followed in accordance with the current IFU, since follow-up has not been amended.
According to the local supplier, the affected products are distributed in Hong Kong
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 March 2017