Following 45 reports of serious adverse events, the FDA is cautioning healthcare providers about using a SentreHeart device in a procedure intended to prevent strokes.
SentreHeart’s Lariat suture delivery device is a tool used to aid in soft tissue closure during surgery. Some surgeons have used the Lariat system off-label — along with three cleared associated SentreHeart devices — for closing the left atrial appendage, a pouch-like region in the left atrium, in patients with atrial fibrillation who have had trouble taking blood thinners. The agency has not evaluated the device for this indication.
In a safety communication, the FDA says it has identified six deaths and other serious complications connected to using Lariat and associated devices in this procedure, including laceration or perforation of the heart, complete LAA detachment from the heart, bleeding, low blood pressure and fluid collection around the heart and lungs. About 34 cases resulted in the need to perform emergency surgery.
Healthcare providers are advised to report any adverse events to the FDA and the manufacturer.
The safety communication comes less than a month after the company reported that the FDA had signed off on the Amaze clinical trial intended to evaluate the Lariat device for closure of the LAA as an adjunct to ablation in patients with persistent or longstanding persistent atrial fibrillation (). Currently, only Boston Scientific’s Watchman LAA closure device is approved as an alternative to warfarin for stroke prevention. — Elizabeth Hollis