Medical device manufacturer, William Cook Europe, has issued a medical device safety alert concerning its Zenith Alpha Thoracic Endovascular Graft (Catalogue Identifier: All ZTA-devices).
The manufacturer has become aware that the Zenith Alpha Thoracic Endovascular Graft has been used to treat patients with thoracic aortic dissections.
As per Instructions For Use (IFU), the graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair, including:
To emphasize best practices, the manufacturer would like to reiterate that the graft and ancillary components should be used as specified in the IFU. The IFU section 4.2 "Patient Selection, Treatment and Follow Up" states that the safety and effectiveness of the Zenith Alpha Thoracic Endovascular Graft and ancillary components have not been evaluated in the patient populations for dissection. Users are also advised to refer to IFU section 5 for potential adverse events associated with either Zenith Alpha Thoracic Endovascular Graft or the implantation procedure that may occur and/or require intervention.
According to the manufacturer, no devices are needed to be returned and patients already treated for a dissection should receive standard follow up procedures.
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 23 August 2018