Pipeline™ Vantage Embolization Device With Shield Technology™

Medtronic is initiating a recall of Pipeline™ Vantage devices with the part numbers PED3-027-XXX-XX, which represents compatibility to 0.027 inch (0.69 mm) inner diameter (id) microcatheters ["Pipeline™ Vantage 027"]. Additionally, Medtronic is issuing a correction to the IFY of pipeline vantage devices with the part number PED3-021-XXX-XX, which represents compatibility to 0.021 inch (0.53 mm) inner diameter (id) microcatheters ["Pipeline™ Vantage 021"].

Medtronic has received reports of incomplete wall apposition and/or braid deformation noted during the procedure and post procedure involving the Pipeline™ Vantage 027 and Pipeline™ Vantage 021 devices. Braid deformation (sometimes termed "fishmouthing", "braid narrowing", or "braid collapse") and incomplete wall apposition are known risks that potentially can lead to thrombosis and/or serious adverse events including stroke or death.

As of 31 December 2024, Medtronic has received reports of incomplete wall apposition and/or braid deformation, including 3 patient deaths and 13 ischemic strokes (from 416 complaints out of approximately 18,200 Pipeline™ Vantage 027 units distributed worldwide). Pipeline™ Vantage 027 devices (diameters ≥4mm) appear to exhibit a higher incidence stent braid deformation compared to the pipeline shield. Additionally, the risk of braid deformation was higher in females, especially females ≤45 years of age. the risk of braid deformation presents either intra-operatively or post-procedurally, with braid deformations typically noted at 6-12-month imaging follow-up.

Comparatively, for Pipeline™ Vantage 021 devices, fewer reports were received for incomplete wall apposition and/or braid deformation with 0 deaths and 4 strokes (from 57 complaints out of approximately 7,400 units distributed). The Pipeline™ Vantage 021 compatible sizes are similar to the pipeline shield product family in design characteristics. The rate of braid deformation for the Pipeline™ Vantage 021 is lower than that observed for Pipeline™ Vantage 027. Based on this information, the removal (retrieval) is only isolated unused inventory of the Pipeline™ Vantage 027 devices.

As part of this recall, Medtronic will correct the IFU of the Pipeline™ Vantage 021 to provide instructions to users on mitigating the risk of incomplete wall apposition and/or braid deformation.

Recall start date: January 30, 2025