Safety Warning – Lariat LAA Closure Devices
The US Food and Drug Administration (FDA) has issued a safety alert regarding serious patient injury and death associated with the use of SentreHEART devices to close the left-atrial-appendage (LAA), including the Lariat suture delivery service.
About the Safety Warning
Medscape.com reports that SentreHEART devices used for left-atrial-appendage (LAA) closure, including the Lariat suture delivery device, are associated with 45 adverse event reports to the FDA, prompting a safety warning from the organization to all healthcare professionals and patients.
The devices have led to patient deaths and other serious medical complications such as laceration or perforation of the heart, LAA detachment from the heart, hemorrhage, hypotension (low blood pressure), and fluid collection around the heart or lung, says the FDA.
The FDA will continue to monitor the issue and emphasizes that the SeatreHEART Lariat and other associated technologies have not yet had their safety and effectiveness approved by the organization. It is important to seek treatment for which safety and effectiveness has been established.
The FDA asks that patients and doctors report adverse events and side effects to the FDA MedWatch Safety Information and Adverse Event Reporting Program online, by fax at 1-800-FDA-0178, or by mail to the address on the pre-addressed form.
FDA Medical Complication Statistics
- 45 adverse events associated with SentreHEART devices have been reported to the FDA.
- 75% of the adverse events, or 34 of the 45, required emergency open-heart surgery, said the FDA.
- 6 patient deaths are associated with the devices.