Lariat Anti-Stroke Device May Cause Death
According to the U.S. Food and Drug Administration (FDA), a device designed to prevent strokes may actually cause various adverse effects, including death.
About the FDA Warning
The Lariat device is made by a company called SentreHeart. It was designed as a stroke prevention device.
The device works by closing off the heart’s left atrial appendage. This closure prevents blood clots from forming in the heart. If the blood clots were allowed to form, then patients with atrial fibrillation would be at risk for a stroke.
MassDevice reports the FDA decided to review SentreHeart’s adverse events database in order to ensure consumer safety. The search uncovered 45 incidents involving the Lariat anti-stroke devices, including 6 deaths.
In addition, 75% of the device-related injuries required emergency heart surgery. The FDA warning made it clear that the safety and effectiveness of the Lariat devices has not been proven. The administration plans to investigate further and alert the public of any new information.
Potential Health Complications from the Lariat Devices
- Laceration of the heart
- Perforation of the heart
- Detachment of the left atrial appendage
- Low blood pressure
- Pericardial and pleural effusion
- Cardiac tamponade