Bolton Medical, part of Terumo Aortic, has issued an urgent medical device recall notice for certain Relay Pro thoracic stent graft systems.
The US Food and Drug Administration (FDA) has identified this recall, which covers the non-bare stent configuration, sizes 32mm and above of the Relay Pro, N4, as the most serious type. This means the device may cause serious injury or death if its use is continued.
On 23 April, Bolton Medical sent all affected customers a letter recommending they consider use of alternative stent-graft options prior to use of impacted RelayPro devices until mitigation measures are in place.
Outlining the reason for the recall, Bolton Medical states that, in some cases, the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. This may be recognised by the user as a lack of resistance felt when sliding the apex holder back accompanied by a failure to release the proximal stent. The implant cannot be recaptured at this stage in the procedure. This failure mode is not able to be recognised until it occurs during the procedure.
Difficulties in releasing the stent graft may result in delay of procedure, stent graft displacement, and an inability to release the stent graft. This may require conversion to open surgical repair to release the clasp and can result in patient death. The company advises that this failure mode can occur without prior warning and no device-based bailout method has been identified for this specific scenario.
As of 23 April, Bolton Medical has reported three deaths associated with this issue, including one aortic perforation and two conversions to open surgery, which resulted in patient deaths due to stroke.
Customers in the USA with adverse reactions, quality problems, or questions about this recall are advised to contact Terumo Aortic.
