Recently, the FDA announced a first level recall of Medtronic's flagship product, the Pipeline Vantage series embolization device. It is reported that the US FDA has listed the recall of the Medtronic (NYSE: MDT) Pipeline Vantage embolization device as the highest level of alert, as the product has initiated an emergency recall procedure due to multiple fatal cases. This recall includes two key measures: complete discontinuation and removal of Pipeline Vantage 027 embolization device; Update the usage guide for Pipeline Vantage 021 device.

This series of neurointerventional devices using shielding technology are mainly used for treating intracranial aneurysm like lesions (aneurysms). Its working principle is to deliver the braided stent to the lesion site through a microcatheter, and block the blood flow of the aneurysm using a mesh structure.

According to the FDA announcement, this recall is due to adverse stent adherence events that occur frequently in clinical use. Specifically, during and after the intervention surgery, the woven stent has instrument defects such as incomplete adhesion of the vascular wall and deformation of the stent structure. Epidemiological analysis shows that female patients (especially those under 45 years old) have a significantly increased risk of stent fish mouth shaped deformation, lumen narrowing, or collapse, which may lead to serious consequences such as thrombosis, stroke, and even death. Case data shows that Pipeline Vantage 027 has been involved in 13 injury events (including 4 deaths); Pipeline Vantage 021 reported 4 cases of injury (with no recorded deaths).

According to Medtronic's emergency recall order for medical devices issued on January 30, 2025, medical institutions should immediately discontinue the 027 product and initiate the return process; Type 021 users must strictly follow the new operating specifications, with a focus on updating the bracket size selection criteria and release technology points. For implanted patients, the attending physician needs to develop an imaging follow-up plan based on individual circumstances and evaluate the risk benefit ratio of dual antiplatelet therapy, especially being alert to complications related to stent structure deformation.

Source: https://news.yaozh.com/archive/45174.html