Patient Deaths Linked to Suture Delivery Device, FDA Warns

Six patient deaths and other serious adverse events have been linked to SentreHeart’s Lariat Suture Delivery Device, the FDA is warning health care professionals.

The FDA has received reports of 45 adverse events associated with the device’s use in closing the left atrial appendage (LAA) to reduce the risk of stroke in patients with atrial fibrillation.

Importantly, the FDA has not evaluated the surgical tool’s safety and effectiveness for this use.

Of the 45 reported adverse events, which included laceration of the heart and hemorrhage, 34 (75%) resulted in the need to perform emergency heart surgery.

The FDA now recommends that health care providers:

• Consider treatment options for which safety and effectiveness have been established to reduce the risk of stroke in patients with atrial fibrillation.
• Inform atrial fibrillation patients of the benefits and risks of available treatment options to help prevent stroke.
• Report any adverse events associated with the use of the device and/or to the FDA and manufacturer.