Burst Balloons Prompt Edwards to Recall Sapien 3 Ultra Delivery System

Reports of balloons bursting during transcatheter aortic valve replacement (TAVR) implantation procedures prompted Edwards Lifesciences to recall 1,585 Sapien 3 Ultra delivery systems from the U.S. market. The company initiated the recall in July but FDA just issued the associated safety alert on Thursday. The 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 recall 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. This is Edwards' fifth recall in 2019.  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, difficulty retrieving the delivery system, and may require subsequent conversion to surgical intervention. FDA has reported a total of 37 medical device recalls so far t...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news