Burst Balloons Prompt Edwards to Add Warning to Sapien 3 Ultra Delivery Instructions

Reports of balloons bursting during transcatheter aortic valve replacement (TAVR) implantation procedures prompted Edwards Lifesciences to issue a field safety notice in July with instructions for physicians who treat patients with the Sapien 3 Ultra valve. FDA issued this safety alert on Aug. 22 calling the action a recall. However, an Edwards spokesperson told MD+DI that the device is not actually being pulled from the market and no devices are being returned as part of this action. The reported incidents of burst balloons during implantation procedures have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, which may cause vascular injury, bleeding, or the need for surgical intervention. The issue has resulted in 17 injuries and one death, FDA noted. The news of this action comes less than a week after FDA expanded indications of transcatheter aortic valves made by both Edwards Lifesciences and Medtronic, making the devices available for use in younger and lower-risk patients. sapien3ultra.jpg In addition to giving physicians specific instructions regarding the risk of balloon rupture and what to do if a balloon burst is suspected, the company will add the following warning to the Sapien 3 Ultra's instructions for use: Failure to use slow, controlled inflation and prescribed nominal inflation volumes may result in balloon rupture, diffic...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news