FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Edwards Lifesciences Warns Doctors About Valve System

July 19, 2019
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Edwards Lifesciences warned users about the risk of balloon breakage when withdrawing the Sapien 3 Ultra transcatheter heart valve system from the patient.

The device is used for severe, symptomatic aortic stenosis patients at intermediate or higher risk of requiring open-heart surgery. The company said that bursting balloons accounted for approximately one percent of complaints.

Edwards has expanded the device’s instructions for use to include a warning about failing to inflate the device slowly. It is also updating the training materials with a new method for retrieving a burst balloon through the sheath.

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