The US Food and Drug Administration has issued a safety communication to healthcare providers reporting deaths and serious adverse events with the use of the Lariat Suture Delivery Device (SentreHeart) and its associated devices used for left atrial appendage closure.
The FDA announced that it identified 45 adverse events through 30 June 2015 with the use of the Lariat device and its associated FDA-cleared devices (EndoCath Occlusion Balloon Catheter, the SofTip Guide Cannula and the FindrWirz system) for left atrial appendage occlusion. The agency reported the events based on information from the Manufacturer and User Facility Device Experience (MAUDE) database. The Lariat device is not FDA-cleared for the prevention of thromboembolic stroke in atrial fibrillation patients.
For atrial fibrillation patients who have difficulties taking anticoagulants, left atrial appendage closure has been proposed as an alternative treatment to reduce the risk of stroke. The only FDA-approved device for this indication is the Watchman (Boston Scientific).
The FDA’s safety communication details six patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, haemorrhage, hypotension, pericardial effusion, cardiac tamponade and fluid pleural effusion. Of the 45 adverse events reported to the FDA, 34 resulted in the need to perform emergency heart surgery.
The agency said that it will continue to monitor this issue and keep the public informed if significant new information becomes available.