Edwards Lifesciences has issued an “urgent field safety notice” after receiving reports of burst balloons during the deployment of its SAPIEN 3 Ultra transcatheter heart valve system.
The company’s notice says the burst balloons “have resulted in significant difficulty retrieving the SAPIEN 3 Ultra delivery system into the sheath and withdrawing the system from the patient.”
Health Canada, the Canadian government’s health regulatory agency, issued a recall of the device last week. The models affected by the recall are 9630TF20, 9630TF23, 9630TF26 and 9630TF29.
Edwards said that its investigation determined two factors that influence the frequency of the balloon burst: excess inflation volume and fast inflation conditions. When deploying the valve, the company said, the balloon should be inflated slowly and continuously throughout deployment and held for 3 seconds at full inflation.
The notice also provides detailed instructions for operators who experience a balloon burst with the SAPIEN 3 Ultra. Read the complete notice here.
The U.S. Food and Drug Administration approved the SAPIEN 3 Ultra in December for transcatheter aortic valve replacement to treat severe symptomatic aortic stenosis in patients at intermediate or greater risk of surgical mortality.