Thoracic Stent Graft Recall Issued by Bolton Medical Following At Least Three Deaths

Recall indicates device malfunctions could increase the risk of complications for those undergoing certain heart procedures.

Federal officials are warning that certain thoracic stent grafts from Bolton Medical may not be able to unclasp from their delivery systems when inserted into blood vessels.

The U.S. Food and Drug Administration (FDA) announced the Bolton Medical thoracic stent graft warning on April 28, updating use instructions and advising customers to consider using alternative stent-graft options until a solution is in place.

Thoracic Stent Graft Risks

A thoracic stent graft is a minimally invasive device used to repair weakened areas of the aorta, such as those caused by aneurysms, dissections or tears. Implanted within the thoracic aorta, a major blood vessel that runs from the heart’s left ventricle through the chest, the device helps restore stability to the artery.

Once in place, the stent expands to reinforce the vessel walls and maintain proper blood flow, often avoiding the need for open surgery. The graft component, typically made of synthetic fabric, lines the interior of the artery and creates a new pathway for blood to flow safely.

However, the FDA warns that in certain Bolton Medical stents, the graft may not be able to unclasp from the delivery system, which is usually a catheter that has been inserted through the femoral artery. A lack of resistance when sliding the stent graft’s holder back along with a failure to release may indicate the malfunction. Once this occurs, the implant cannot be recaptured. As a result, the failure cannot be detected until it occurs during a procedure.

This may delay treatment, cause device displacement, or prevent use of the stent graft altogether. As a result, medical professionals may have to resort to open surgery to release the clasp, which could result in severe injury or death.

Bolton Medical Thoracic Stent Graft Recall

Bolton Medical has reported at least three deaths associated with the stent graft issue, including one aortic perforation and two cases requiring conversion to open surgery that resulted in patient deaths due to stroke.

Affected customers were sent a letter on April 23, recommending that medical personnel consider alternative stent-graft options prior to using the impacted Bolton Medical Relay Pro Thoracic Stent Graft Systems, N4 non-bare stent configuration (32 mm and above).

If there is difficulty releasing the stent and no resistance is felt when sliding the device holder back, users should first attempt solutions listed in the Instructions for Use (IFU). If unsuccessful, no additional methods are available, and clinical judgment should guide the provider’s next steps, including possible conversion to open surgery.

All users of the Relay Pro should be informed of additional guidance for managing cases in which the stent graft cannot be released from the delivery system. Copies of the Urgent Medical Device Recall notice along with the IFU should be posted where devices are stored.

If the stent grafts have been transferred to another facility, a copy of the notification should be provided, as well as instructions to follow the outlined actions.

For more information, customers may contact Terumo Aortic, Bolton Medical’s parent company, at Market_Actions-TMC@terumomedical.com.

Health care providers and consumers can also report adverse events or product quality issues related to these devices through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

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