Updates to Instructions for Use of Medtronic Abre™ Venous Self-expanding Stent System to mitigate the risk of possible stent migration

A Dear Healthcare Professional Letter has been issued by Medtronic International Ltd to inform healthcare professionals of upcoming updates to the Instructions for Use (IFU) for the Medtronic Abre^™ Venous Self-expanding Stent System. These updates will provide new information to help mitigate the risk of possible stent migration. Through 31 October 2021, there have been four complaints of stent migration (a failure rate of 0.0157%). There are no reports of any manufacturing-related device failures for these complaints and no product retrieval is necessary or requested. However, 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. Medtronic, in consultation with an Independent Physician Panel, concluded that some modification of use may help to reduce the risk of possible stent migration and is updating the Abre^™ IFU to provide new information for users. Healthcare professionals are advised to review the upcoming IFU updates attached with this letter to help mitigate the risk of possible stent migration. Please refer to the letter for details. Published: 25 Nov 2021

Dear Healthcare Professional Letters