Medical device manufacturer, William Cook Europe, has issued a field safety notice concerning Zenith Alpha Thoracic Endovascular Graft [Reference number: 2015FA0001].
The manufacturer identified a few cases 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. These findings were found to be associated with thoracic aneurysms treated with a single proximal component that resulted in a short distal seal length (i.e., less than 20 mm) and likely inadequate (i.e., less than 10%) distal oversizing for the device.
The manufacturer has revised the Instructions for Use to include additional warnings and precautions on the above issues.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 February 2015