FDA Issues Safety Communication on Off-Label Use of Lariat Device for LAA Closure in AF Patients

July 13, 2015—The US Food and Drug Administration (FDA) has issued a safety communication alerting health care providers and patients of reports of patient deaths and other serious adverse events associated with the use of the Lariat suture delivery device (SentreHeart, Inc.) and its associated devices to close the left atrial appendage (LAA) in patients with atrial fibrillation (AF) to prevent stroke.

According to the FDA, some physicians are using the Lariat suture delivery device along with three other cleared associated SentreHeart devices (the EndoCath occlusion balloon catheter, the SofTip guide cannula, and the FindrWirz system) to close the LAA. The FDA advised that it has not evaluated the use of the Lariat suture delivery device for LAA closure to reduce the risk of stroke in AF patients. The Lariat is a surgical tool cleared by the FDA to deliver a suture to aid in soft tissue closure during surgery.

The safety communication stated that the FDA conducted a search of the MAUDE database of manufacturer and user-facility device experience for reports of adverse events with the use of the Lariat and its associated devices. The FDA identified 45 adverse events through June 30, 2015 that occurred in patients undergoing LAA closure procedures with the Lariat device and/or its associated devices. These reports describe six patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, hemorrhage, hypotension, pericardial effusion, cardiac tamponade, and pleural effusion. Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery.

Providers or patients who suspect or experience a problem with the Lariat suture delivery device and/or its associated devices are encouraged to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user-facility reporting requirements should follow the reporting procedures established by their facilities, stated the FDA.

The FDA will continue to monitor this issue and keep the public informed if significant new information becomes available. The agency stated that health care providers should report any adverse events associated with the use of the Lariat suture delivery device and/or its associated devices to the FDA and the manufacturer.

Additionally, the FDA recommends that providers should be aware that the safety and effectiveness of the Lariat suture delivery device to close the LAA and prevent stroke in patients with AF has not been established. To reduce the risk of stroke in patients with AF, they should consider treatment options for which safety and effectiveness have been established. Before treatment, providers should inform AF patients of the benefits and risks of the available treatment options to help prevent stroke.

Patients who have already undergone LAA closure with the Lariat device and have questions regarding treatment should continue routine follow-up with their physicians. They also need to be aware that the safety and effectiveness of the Lariat device to close the LAA and prevent stroke in patients with AF has not been established and to know that there are FDA-approved treatments to reduce the risk of stroke associated with AF. Finally, patients should know that there are benefits and risks associated with all medications, medical devices, and medical procedures and that before making a treatment selection, they should ask their health care providers to review treatment options to reduce the risk of stroke.