When used in “off-label” heart surgeries, the LARIAT Suture Delivery Device has been linked to dozens of severe adverse events, including six deaths.
The LARIAT is a surgical tool that delivers a pre-tied stitch to close soft-tissues. Unfortunately, it is commonly used “off-label” to close the left atrial appendage (LAA), a pouch in the heart that is believed to be the source of blood clots that cause strokes in people with atrial fibrillation.
If you have atrial fibrillation and your doctor has suggested closing the LAA to reduce your risk of stroke, be aware that the FDA has approved other devices specifically for this purpose.
The Lariat device has never been tested in clinical trials or approved for LAA closure, and studies have shown that 2.3% of patients needed emergency open heart surgery to correct life-threatening complications.
In July 2015, the FDA issued a Safety Alert to report 45 severe adverse events, including six deaths, in patients who were treated with the Lariat device for LAA closure — and 75% of those patients needed emergency heart surgery.
What is the problem?
The Schmidt Firm, PLLC is nationally recognized as a class action law firm, but our lawyers are not filing a Lariat device class action against SentreHeart Inc. Instead, we are filing individual lawsuits on behalf of people with severe injuries.
Lariat Device Safety Risks
- Heart laceration and/or perforation
- Bleeding (hemorrhage)
- Pericardial effusion (fluid collection around the heart)
- Cardiac tamponade
- Fluid collection around lungs