July 13, 2015 - The U.S. Food and Drug Administration (FDA) is alerting healthcare providers and patients about reports of patient deaths and other serious adverse events associated with the use of the SentreHEART Lariat Suture Delivery Device used for minimally invasive surgical closure of the left atrial appendage (LAA). The LAA is a pouch-like region of the left atrium that is implicated as the source of stroke causing clots in patients with atrial fibrillation.
The FDA said it 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, low blood pressure, 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 percent) resulted in the need to perform emergency heart surgery.