Edwards Lifesciences issues an urgent field safety notice for Centera TAVI system


After receiving reports of difficulty tracking and manipulating the Centera transcatheter aortic valve implantation (TAVI) system around the aortic arch, Edwards Lifesciences has issued an urgent safety notice. The notice states that these difficulties have “resulted in vascular injury including aortic dissection and death during early cases”.

It adds: “A thorough investigation of these reports concluded that tracking difficulty is more likely to occur when the device is used in specific tortuous aortic anatomies. The observed incidence of serious events related to this issue is approximately 1.50% based on the limited global experience with this device to date.” These specific anatomies include those with multiplanar curvature of the aorta and those with extremely dilated innominate trunks or acute angulation of the aortic arch. According to the notice, when faced with these anatomies, operators should, respectively, consider alternative treatment options and use a stiffer guidewire to avoid tracking difficulties.

Furthermore, the notice advises that a computed tomography (CT) angiogram of the chest-abdomen-pelvis may be necessary to properly assess the ascending, transverse and descending aorta. “This assessment ensures the aorta is suitable to accommodate the delivery system distal stiff section and that the aorta is free from tortuosity or disease that may prevent the safe usage of the Centera system,” it explains.

Other recommendations in the notice include following guidelines and instructions provided in the Centera system training materials and being aware of new instructions that have been added to the IFU (instructions for use) for the Centera system.

Click here for the full safety notice.


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