UNITED STATES – As reported in an online news article published by www.medtechdive.com, Edwards Lifesciences has issued a safety alert after the company received reports of balloons bursting associated with the delivery system for the company’s Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) system.
Edwards Lifesciences recently recalled its IntraClude intra-aortic occlusion device following reports of three deaths linked to ruptured cardiovascular balloons used with the IntraClude devices. Less than a month later, Edwards Lifesciences is notifying all health care providers and patients of a safety concern regarding the company’s Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) system.
The Sapien 3 Ultra is a medical device used in patients with severe symptomatic aortic stenosis and patients who are at intermediate or greater risk of undergoing open-heart surgery. The Sapien was designed with a new delivery system that was intended to simplify the procedure. According to Edwards Lifesciences, there are reports of balloons bursting associated with the Sapien 3 Ultra’s delivery system, making it difficult to remove the device from a patient’s body.
In its safety alert, Edwards Lifesciences indicates that the problem of balloon bursting as it relates to the Sapien 3 Ultra’s delivery system resulted in vascular injury, bleeding, difficulty removing the device, and the need for further surgical intervention. Edwards Lifesciences reported a 1 percent complaint rate with 0.5 percent of these complaints having “clinical implications” for patients. The number of patient injuries was not reported, and so far, there have been no reported deaths.
Edwards Lifesciences reports that balloon bursting is influenced by two factors – (1) excess inflation volume, and (2) fast inflation conditions. The company plans to add a warning to the Sapien 3 Ultra’s labeling stating that failure to use slow, controlled inflation and prescribed nominal inflation volumes may lead to balloon rupture and difficulty retrieving the device from a patient’s body. Balloon bursting may also require an additional surgical procedure in some patients.
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