AUDIENCE: Cardiology, Internal Medicine, Risk Manager
ISSUE: FDA is 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 and its associated devices to close the left atrial appendage, a pouch-like region of the left atrium in the heart, in patients with irregular heart rhythm (atrial fibrillation) to prevent stroke.
FDA identified 45 adverse events through June 30, 2015 that occurred in patients undergoing LAA closure procedures with the Lariat Suture Delivery Device and/or its associated devices. These reports describe 6 patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery.
The FDA will continue to monitor this issue and keep the public informed if significant new information becomes available.
BACKGROUND: 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 has not evaluated the use of the Lariat Suture Delivery Device for LAA closure to reduce the risk of stroke in atrial fibrillation patients.
RECOMMENDATION: Health professionals should be aware that the safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established. See the FDA Safety Communication for recommendations for patients and additional information.
To reduce the risk of stroke in patients with atrial fibrillation, consider treatment options for which safety and effectiveness have been established. Prior to treatment, inform atrial fibrillation patients of the benefits and risks of the available treatment options to help prevent stroke.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[07/13/2015 - FDA Safety Communication - FDA]