The FDA has issued an early alert for a thoracic stent graft issue from Bolton Medical after three deaths associated with the issue.
Bolton Medical sent an urgent medical device recall notice for all Relay Pro Thoracic Stent Graft Systems, N4: Non-Bare Stent Configuration 32mm and above, according to an April 28 news release from the FDA.
In some cases, the graft is unable to unclasp from the delivery system due to the proximal clasp being disconnected from the outer control tube. Issues releasing the graft can lead to procedure delays and stent graft displacement.
The minimally invasive device is used to repair damaged or weakened sections of the thoracic aorta by placing a stent graft to reinforce the vessel and maintain blood flow.
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