The FDA alerted 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.
The LARIAT Suture Delivery Device, manufactured by SentreHEART, is a surgical tool cleared by the FDA to deliver a pre-tied stitch (suture) to aid in soft tissue closure during surgery.
Atrial fibrillation is a common heart rhythm problem in which the heart beat (pulse) is irregular because the upper chambers of the heart (the left atrium and right atrium) do not contract normally. As a result, a blood clot (thrombus) can form in the part of the heart called the left atrial appendage (LAA). If a blood clot in the LAA detaches and travels through the bloodstream to the brain, it can block a brain blood vessel resulting in a stroke and brain damage. To reduce the chance of blood clots, atrial fibrillation patients are often prescribed blood thinning medications (anticoagulants). However, some patients with atrial fibrillation have difficulty taking blood thinners because of bleeding or other side effects.
For atrial fibrillation patients who have difficulties taking blood thinning medication, LAA closure has been proposed as an alternative treatment to reduce the risk of stroke by preventing a blood clot that might form in the LAA from entering the bloodstream. 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 conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database for reports of adverse events with the use of the LARIAT Suture Delivery Device and its associated devices. It 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 six 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.
Health care providers and patients 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. The FDA will continue to monitor this issue and keep the public informed if significant new information becomes available.
See the FDA Safety Alert
See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death