According to a safety alert issued by the U.S. Food and Drug Administration (FDA), the use of Lariat Suture Delivery Device has been linked to reports of patient deaths and other serious complications when used to close the left atrial appendage (LAA) in patients with atrial fibrillation. The LAA is a pouch-like region located in the left atrium of the heart. There is a risk of LAA blood clots in patients with atrial fibrillation, which can lead to stroke and brain damage if part of the clot breaks off and gets lodged in a blood vessel of the brain.
The Lariat Suture Delivery Device is manufactured by SentreHeart. It was approved to deliver a pre-tied stitch to help close soft tissue during surgery. The FDA emphasizes that the device has not been established for LAA closure.
Atrial fibrillation patients are often prescribed blood thinners to reduce the risk of blood clots forming in the LAA. Closure of the LAA is sometimes performed in patients who have trouble taking blood thinners. According to the FDA Safety Communication, “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.”
The FDA found 45 adverse events through June 30, 2015 in patients undergoing LAA closures with the Lariat Suture Delivery Device, the notification states. The events include 6 patient deaths and report of serious medical problems, 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), according to the FDA. Emergency heart surgery had to be performed in three-quarters of the adverse events. These events were identified using the Manufacturer and User Facility Device Experience (MAUDE) database.