Medtronic Recalls Pipeline Vantage Embolization Devices After Reports of Death

Medtronic Neurovascular is recalling 027 compatible Pipeline Vantage embolization devices and updating instructions for use (IFU) for 021 compatible Pipeline Vantage embolization devices.

Pipeline Vantage embolization devices with Shield technology are used to treat aneurysms of the brain. These devices are inserted into the blood vessels through a small catheter and delivered to the aneurysm location, where a small, braided tube is placed to block off blood flow to the bulging area.

The recall was initiated because of reports of a higher incidence of the flexible, braided tube part of the device failing to correctly attach or remain attached to the blood vessel wall (incomplete wall apposition and/or braid deformation) during and after procedures using the devices. These issues, sometimes called fish-mouthing, braid narrowing, or braid collapse, are known risks of these devices.

The risks were notable higher in females, especially those younger than 45. There have thus far been thirteen reported injuries and four reports of death related to the 027 compatible device, and dour reported injuries and no reports of death related to the 021 compatible device.

Customers were advised to not use and return all unused Pipeline Vantage 027 devices. They were encouraged to read updated instructions before using Pipeline Vantage 021 devices.

The updated IFU provided by Medtronic aims to help achieve optimal device size selection and stent brain deployment to reduce complication risk by lowering the incidence of incomplete wall apposition and/or braid deformation.

Revisions include consideration to appropriately select diameter and length accounting for complex anatomy. Techniques to deploy Pipeline Vantage compared to Pipeline Shield using a balance of device tension and compression were also included. This aims to achieve adequate wall apposition and in tortuous vessels.

Warnings about the consequences of incomplete wall apposition and suboptimal deployment, as well as increased risk of braid deformation in females—especially those under 45—are also included.

For both devices, the treating physician should determine the need for follow-up imaging or changes to medical management based on the patient’s overall health. This includes weighing the risks of dual antiplatelet therapy against potential risks for braid deformation.