Feature | Left Atrial Appendage (LAA) Occluders | July 13, 2015

FDA Announces Safety Issues With Lariat Left Atrial Appendage (LAA) Closure Device

FDA reports of patient deaths and other serious adverse events

sentraheart lariet, LAA occlusion, FDA safety alert

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.

The FDA said will continue to monitor this issue and keep the public informed if significant new information becomes available. 
Some physicians are using the Lariat 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 for LAA closure to reduce the risk of stroke in atrial fibrillation patients. For this reason, the FDA recommends health professionals should be aware that the safety and effectiveness of the Lariat to close the LAA and prevent stroke in patients with atrial fibrillation has not been established.
The FDA said to reduce the risk of stroke in patients with atrial fibrillation, physicians should consider treatment options for which safety and effectiveness have been established. Prior to treatment, inform atrial fibrillation patients of the benefits and risks of the available treatment options to help prevent stroke.  
For more information: 

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