Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Abre venous self-expanding stent system.
The manufacturer is informing users of upcoming updates to the Instructions for Use (IFU) for the affected product. These updates will provide new information to help mitigate the risk of possible stent migration. According to the manufacturer, through 31 Oct 2021, there have been four complaints of stent migration (a failure rate of .0157%) resulting in three endovascular stent retrievals and one open surgical stent retrieval. Stent migration can potentially lead to vessel occlusion, thrombus formation, vessel damage, embolism, and/or need for surgical intervention. Stent migration to the central vasculature can result in permanent impairment or death.
The manufacturer is updating the IFU to provide new information for users. Affected users should follow the action listed on the customer letter issued by the manufacturer.
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 25 Nov 2021