The FDA recently released an alert to healthcare professional regarding the Lariat Suture Delivery Device, manufactured by SentreHEART. The device uses a tiny lasso like mechanism to stitch tissues in the body. Although it has been approved for use by the FDA it was not approved to suture tissues of the heart. The FDA reported 45 adverse events in patients undergoing Left Atrial Appendage (the LAA is a pouch like region in the left atrium of the heart) closure procedures with the Lariat Suture Delivery Device and/or its associated devices, including 6 deaths.
The Lariat Suture Device was being used to close of the LAA in patients with irregular heartbeat to prevent stroke. According to the FDA complication of the procedure include:
- laceration and/or perforation of the heart,
- complete LAA detachment from the heart,
- low blood pressure,
- fluid collection around the heart (pericardial effusion),
- fluid collection leading to shock (cardiac tamponade), and
- fluid collection around the lung (pleural effusion).
Of the 45 adverse events known to the FDA, approximately 75% required emergency heart surgery. The number of adverse events is likely higher than stated due to underreporting.
The FDA cleared the Lariat as part of a fast-track process known as the 510 (k) program. The program allows companies to avoid years of costly clinical trials, by piggybacking approval off another similar device that has already been approved. There was no reference to the word “heart,” “stroke,” or atrial fibrillation in the Lariat’s 510 (k) application. However, the company’s trademark application for the Lariat states it is “for treating diseases of the heart, specifically for ligating the left atrial appendage of the heart.” The FDA has not assessed the safety of the Lariat for LAA closure and therefore recommends that health professionals be aware that safety and effectiveness has not been established.
If you have been injured by this or any other medical device, call the attorneys at Rheingold, Giuffra, Ruffo & Plotkin LLP. We have experience in medical device litigation and can help you recover for your injuries. You contact us online here, or by telephone at 800-349-0004 for your free consultation today.