Edwards Lifesciences (NYSE:EW) issued an urgent field safety notice this week warning customers that it received reports of difficulty tracking and manipulating its Centera TAVR system around the aortic arch.
The company said that the issue has caused vascular injury including aortic dissection and death during early cases. The observed incidence of serious events related to the problem is roughly 1.5%, according to Edwards.
The tracking difficulty, Edwards said, is more likely to happen when the Centera device is used in “specific tortuous aortic anatomies.” The company said it plans to add new instructions to the IFU for Centera, including recommendations to use a stiffer guidewire in anatomies with extremely dilated innominate trunks or acute angulation of the aortic arch. Edwards also recommended that for people with extreme aortic tortuosity, providers should consider using alternative treatment options.
The model numbers included in the urgent field safety notice for Centera were 9551S23, 9551S26 and 9551S29. Edwards could not be immediately reached for comment.
Edwards won CE Mark approval in the European Union for Centera in February last year for the treatment of symptomatic aortic stenosis patients who are at a high risk of open-heart surgery.
