Medical Devices

Use of LARIAT Suture Delivery Device for Left Atrial Appendage Closure: FDA Safety Communication

Date Issued: July 13, 2015


Audiences:

Health care providers who treat patients with atrial fibrillation

Patients with atrial fibrillation

Specialties: Interventional Cardiology, Electrophysiology, General Cardiology, Internal Medicine
 
Device: 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.
 
Purpose: The FDA is alerting 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. 
 
Summary of Problem and Scope:
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.  We 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 6 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.
 
Recommendations
For Health Care Providers:
  • 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.
  • To reduce the risk of stroke in patients with atrial fibrillation, consider treatment options for which safety and effectiveness have been established.

  • Prior to treatment, inform your atrial fibrillation patients of the benefits and risks of the available treatment options to help prevent stroke.
  • Report any adverse events associated with the use of the LARIAT Suture Delivery Device and/or its associated devices to the FDA and the manufacturer.
For Patients:
  • 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. 
  • Note that there are FDA-approved treatments to reduce the risk of stroke associated with atrial fibrillation. 
  • Know that there are benefits and risks associated with all medications, medical devices, and medical procedures. Before making a treatment selection, ask your health care provider to review treatment options to reduce the risk of stroke. 
  • Routine follow-up with your physician is recommended if you have already undergone LAA closure with the LARIAT Suture Delivery Device and have questions regarding your treatment.
 
FDA Actions:
The FDA will continue to monitor this issue and keep the public informed if significant new information becomes available. 
 
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks related to the use of medical devices. If you suspect or experience a problem with the LARIAT Suture Delivery Device and/or its associated devices, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
 

Contact Information: If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.

Page Last Updated: 07/13/2015
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