Edwards Lifesciences has issued an urgent safety notice for the latest generation of its Sapien device, Sapien 3 Ultra, after it received reports of “burst balloons, which have resulted in significant difficulty retrieving the Sapien 3 Ultra delivery system into the sheath and withdrawing the system from the patient”. The safety notice comes less than a month after the company issued a safety notice for its self-expanding Centera device (related to the problems with tracking and manipulating the system).
In the safety notice for the Sapien 3 Ultra device, Edwards state: “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. Following investigations into these events, Edwards has not identified any evidence of devices that did not conform to specifications.”
It adds that it has found two factors that influence the frequency of the balloon bursting: excess inflation volume and fast inflation conditions. According to Edwards, the instructions for use for Sapien 3 Ultra already provide advice about inflating the balloon, such as “when deploying the valve, inflate the balloon slowly and continuously throughout deployment”.
However, the company has now added a warning to the instructions of use for the device. The warning says: “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.”
Should the balloon burst, in the notice, Edwards provides recommendations on how to retrieve the balloon through the sheath but it does say that these recommendations “may not resolve all retrieval scenarios”. It also says it is in the process of updating the training materials for Sapien 3 Ultra with the new advice.
For the complete letter, click here.