FDA warns public about vascular device after 3 deaths
The U.S. Food and Drug Administration (FDA) is warning the public about a potential safety issue with certain Relay Pro Thoracic Stent Grafts from Terumo Aortic.
These devices are used by interventional cardiologists and vascular surgeons to repair damaged or weakened sections of a patient’s thoracic aorta. However, Terumo Aortic has received multiple reports of the stent being unable to unclasp from the delivery system. When this happens, it can lead to significant risks, including death. As of April 23, in fact, three deaths have been directly linked to this issue.
“Difficulties in releasing the stent graft may result in delay of procedure, stent graft displacement, and an inability to release the stent graft,” according to the FDA’s warning. “This may require conversion to open surgical repair to release the clasp and can result in patient death. Please be advised that this failure mode can occur without prior warning and no device-based bailout method has been identified for this specific scenario.”
Which devices are included in this warning?
This early alert specifically covers the non-bare stent configuration, sizes 32 mm and above, of the Relay Pro Thoracic Stent Graft System, N4. Bolton Medical is the original manufacturer of these devices, though that company is now a part of Terumo Aortic.
Image courtesy of Bolton Medical/Terumo Aortic.
What should customers do?
Terumo Aortic is recommending that customers consider using an alternative device until “mitigation measures are in place.” Until then, if these Relay Pro Thoracic Stent Grafts are used, the company said users should attempt the bailout techniques listed in the instructions for use; if these are not effective, the user may need to convert the operation to an open surgery.
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More information to come
This early alert from the FDA is intended to help keep the public informed about potential safety issues while they are still under investigation. Read more about that program here.
Cardiovascular Business will provide an update when the FDA has finalized any recalls.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.