Edwards Warns of Balloon Burst Risk With Sapien 3 Ultra for TAVR

Patrice Wendling

Disclosures

July 22, 2019

Edwards Lifesciences has issued a field safety notice regarding its Sapien 3 Ultra system for transcatheter aortic valve replacement (TAVR), warning physicians it has received reports of burst balloons.

The balloon bursts have resulted in "significant difficulty retrieving the SAPIEN 3 Ultra delivery system into the sheath and withdrawing the system from the patient," according to the notice, sent to US customers July 10.

The US Food and Drug Administration has been notified, as have customers outside the United States, Edwards spokesperson Sarah Huoh told theheart.org | Medscape Cardiology via email.

Although the number of reports was unspecified, the Irvine, California-based company said the observed complaint rate is approximately 1% based on "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."

Health Canada issued a medical device recall July 16 for the Sapien 3 Ultra that was classified as type 1, indicating that the device "may be hazardous to health."

The Sapien 3 Ultra system earned CE mark approval in Europe in November 2018 and FDA approval the following month. The system features enhancements to the valve, including a heightened outer skirt design, and a new delivery system and sheath.

Edwards did not identify any evidence of devices that "did not conform to specifications" but determined that "excess inflation volume and fast inflation conditions" may influence the frequency of balloon bursts, according to the field notice. A warning will be added to the system's instructions for use to avoid the problem.

Training materials for the Sapien 3 Ultra system also are being updated and will include recommendations on how best to retrieve a burst Sapien 3 Ultra balloon through the sheath, which was information identified by the investigation and included in the field notice.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.

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