​Edwards—SAPIEN 3 Ultra Transcatheter Heart Valve Systems: Balloon May Burst

​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ECRI.org​.

In an Urgent Field Safety Notice letter posted by the German Federal Institute for Drugs and Medical Devices (BfArM), Edwards states that it has received reports of burst balloons, resulting in significant difficulty retrieving the above systems into the sheath and withdrawing the system from the patient. The overall observed complaint rate for balloon burst is approximately 1% based on the limited experience with the device, of which approximately 0.5% had clinical implications for the patient, such as difficulty removing the delivery system, vascular injury, bleeding, and/or need for surgical intervention. Valve deployment was successful in these cases. Edwards also states that following investigations into these events, the firm has not identified any evidence of devices that did not conform to specifications. Edwards further states that its investigation has determined two factors that influence the frequency of balloon burst: excess inflation volume and fast inflation conditions. Health Canada states that Edwards initiated...