Intra-operative and post-operative incomplete wall apposition and/or braid deformation of Pipeline™ Vantage devices

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals about the recall of Pipeline Vantage devices with the part numbers PED3-027-XXX-XX [“Pipeline Vantage 027”], and a correction in the Instructions For Use (IFU) of Pipeline Vantage devices with the part number PED3-021-XXX-XX [“Pipeline Vantage 021”]. These devices are part of the Pipeline™ Vantage Embolization Device with Shield™ Technology range.

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. These events are known risks that potentially can lead to thrombosis and/or serious adverse events including stroke or death.

Healthcare professionals are advised to identify, quarantine and return affected models of Pipeline Vantage 027 devices to Medtronic. For Pipeline Vantage 021 devices, healthcare professionals are advised to refer to the updated IFU enclosed with the letter that carries instructions to users on mitigating the risk of incomplete wall apposition and/or braid deformation.

For patients implanted with affected devices, healthcare professionals are advised to consider the need for follow-up imaging and/or changes in their medical management according to accepted guidelines, taking into consideration the patient’s overall health. The risks of dual antiplatelet therapy (DAPT) should be weighed against the potential risk posed by braid deformation.

Please refer to the letter for details.

Published: 6 Feb 2025

Dear Healthcare Professional Letters