The FDA today warned healthcare providers about the possibility of potentially deadly adverse effects from the Lariat anti-stroke device made by SentreHeart, saying a review of its adverse events database turned up 45 incidents involving Lariat, including 6 deaths.
The Lariat device is designed to close off the heart’s left atrial appendage, to prevent blood clots from forming there that could later cause stroke in patients with atrial fibrillation. The FDA said the reports from its Manufacturer & User Facility Device Experience database included complications from the Lariat procedures that included laceration and/or perforation of the heart, complete LAA detachment, hemorrhage, low blood pressure, pericardial and pleural effusion and cardiac tamponade.
Of the 45 events reported in the MAUDE database, 34 or roughly 75% required emergency heart surgery, the federal safety watchdog said. Healthcare providers 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 said.
Just last month the agency approved an investigational device exemption for the Amaze clinical trial of the Lariat device.
The FDA said it plans to continue to monitor the issue and inform the public of any significant developments.