FDA Warns on SentreHEART, Inc.'s Anti-Stroke Device
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.
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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.
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