The US Food and Drug Administration (FDA) has released an alert regarding the possibility of increased image artifact associated with magnetic resonance angiography (MRA) imaging.
When MRA is performed as follow-up on patients with implanted neurovascular embolization coils containing 304V stainless steel, the images may contain “larger than expected MR artifact or image voids when compared to other metals.” As a result, the reduced quality of the MRA image may lead to inaccurate clinical diagnoses and later, inappropriate medical decisions.
Neurovascular embolization coils are used in the treatment of brain aneurysms and other vascular conditions.
They are prescription devices that are implanted into the aneurysm sac to occlude blood flow and promote thrombosis. Because aneurysms treated with these coils may have residual filling, placing the patient at risk for late hemorrhage, follow-up imaging may be necessary.
The agency has advised healthcare professionals to be aware of the presence of 304 stainless steel in the coil system, which is typically used in the implant itself or left behind as part of the detachment process. If the provider is uncertain, the FDA recommends contacting the device manufacturer for information. Providers may also choose to use the following optimal imaging parameters to minimize image artifact: shortest echocardiography time and high readout bandwidth.
The FDA will continue to monitor this issue and will report any new information as it becomes available. For more information or to report a problem, please visit the FDA’s MedWatch Safety Information and Adverse Event Reporting Program site.
Neurovascular embolization coils: healthcare provider letter – potential for increased image artifact when using magnetic resonance angiography for follow-up [news release]. Silver Spring, Maryland: US Food and Drug Administration; March 12, 2018. Accessed March 20, 2018.