The SAPIEN 3 Ultra delivery system of Edwards is being recalled by the organization. It is required for delivering and deploying the Edwards SAPIEN 3 Ultra transcatheter heart valve or the Edwards SAPIEN 3 transcatheter heart valve for replacement of a diseased aortic valve without the need of open-heart surgery.
The indication for Edwards SAPIEN 3 Transcatheter Heart Valve System is in patients with severe, symptomatic, aortic valve stenosis (heart’s aortic valve narrowing that causes restriction in blood flow to aorta, the body’s main artery).
Reports have been upraised and received by Edwards Lifesciences regarding burst balloons during implantation procedures, which led to significant difficulty in retrieval of the valve into the catheter and withdrawing the system from the patient, which may further cause vascular injury, bleeding, or surgical intervention. The usage of affected product may cause serious adverse health consequences, including death.
The identified issue is considered as a Class I recall by FDA, which is the most serious type of recall. Use of these devices may cause serious injuries or death.
An Urgent Field Safety Notice was sent by Edwards Lifesciences to customers with the recommendations and instructions for physicians.
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