FDA News

FDA: Neurovascular embolism coil may cause MR angiography inaccuracies

The FDA issued a statement on the potential for increased image artifact associated with magnetic resonance angiography imaging during follow-up after certain procedures involving neurovascular embolization coils for treatment of brain aneurysms and other vascular abnormalities.

An FDA review suggests that when MR angiography is performed on patients’ neurovascular embolization coil implants containing 304V stainless steel, MR angiography images may contain larger-than-expected MR artifact, or image voids compared with other metals.

According to the statement, the reduced quality of the MR angiography image from increased artifact can result in inaccurate clinical diagnoses and inappropriate medical decisions.

The recommendation from the FDA states that health care providers should:

Be aware of the presence of 304V stainless steel in the coil system(s) typically used (either as part of the coil implant itself, or left behind as part of the detachment process). If uncertain, the applicable device manufacturer should be contacted for information about the coil, its detachment mechanism, and any specific recommendations regarding the use of MR angiography with their product;

Understand that 304V stainless steel-containing embolization coil systems may increase image artifact on MR angiography exams performed at the time of aneurysm follow-up. In these situations, X-ray based digital subtraction angiography should be considered;

Use optimal imaging parameters to minimize image artifact if choosing to use MR angiography for follow-up, including shortest echocardiographic times and high readout bandwidth and ensure that the site’s MRI system meets all conditions provided in the MRI-conditional labeling of the coil system.

Report any event of image artifact associated with MR angiography that might have led to misinterpretation of the image to MedWatch, the FDA Safety Information and Adverse Event Reporting Program Online Voluntary Reporting Form.

The FDA issued a statement on the potential for increased image artifact associated with magnetic resonance angiography imaging during follow-up after certain procedures involving neurovascular embolization coils for treatment of brain aneurysms and other vascular abnormalities.

An FDA review suggests that when MR angiography is performed on patients’ neurovascular embolization coil implants containing 304V stainless steel, MR angiography images may contain larger-than-expected MR artifact, or image voids compared with other metals.

According to the statement, the reduced quality of the MR angiography image from increased artifact can result in inaccurate clinical diagnoses and inappropriate medical decisions.

The recommendation from the FDA states that health care providers should:

Be aware of the presence of 304V stainless steel in the coil system(s) typically used (either as part of the coil implant itself, or left behind as part of the detachment process). If uncertain, the applicable device manufacturer should be contacted for information about the coil, its detachment mechanism, and any specific recommendations regarding the use of MR angiography with their product;

Understand that 304V stainless steel-containing embolization coil systems may increase image artifact on MR angiography exams performed at the time of aneurysm follow-up. In these situations, X-ray based digital subtraction angiography should be considered;

Use optimal imaging parameters to minimize image artifact if choosing to use MR angiography for follow-up, including shortest echocardiographic times and high readout bandwidth and ensure that the site’s MRI system meets all conditions provided in the MRI-conditional labeling of the coil system.

Report any event of image artifact associated with MR angiography that might have led to misinterpretation of the image to MedWatch, the FDA Safety Information and Adverse Event Reporting Program Online Voluntary Reporting Form.