FDA Warns of Patient Deaths, Serious Complications When Lariat Suture Delivery Device is Used for Unapproved Procedure

The U.S. Food and Drug Administration (FDA) warns that use of the Lariat Suture Delivery Device, manufactured by SentreHeart, is associated with reports of patient deaths and serious adverse events when used for an unapproved procedure. According to a Safety Communication, reports of serious, sometimes deadly events have occurred when the device is used to close the left atrial appendage (LAA) in patients with atrial fibrillation. The notification states that the Lariat Suture Delivery Device is only approved to deliver a pre-tied stitch to help close soft tissue during surgery; its role in LAA closure has not been established.

Patients with atrial fibrillation have an irregular heartbeat that can lead to a blood clot in the LAA, a pouch-like region located in the left atrium of the heart. Blood thinners are often prescribed to prevent stroke, but closure of the LAA is sometimes an alternative when medication is not an option. The FDA Safety Communication states that , “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.”

Using the Manufacturer and User Facility Device Experience (MAUDE) database, the FDA identified 45 adverse events through June 30, 2015 in patients undergoing LAA closures with the Lariat Suture Delivery Device. According to the Safety Communication, the events include 6 patient deaths and reports 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). In 75 percent of the adverse event reports, emergency heart surgery had to be performed.

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