When the LARIAT Suture Delivery Device is used “off-label” for left atrial appendage (LAA) closure, it has been linked to severe side effects and death.
SentreHeart Inc. manufactures the LARIAT Suture Delivery Device, a snare-like surgical tool that is approved by the FDA to close soft-tissues with a pre-tied stitch. Unfortunately, many surgeons are using it “off-label” for unapproved heart surgeries in patients with atrial fibrillation (AF), a type of irregular heart rhythm.
People with AF are at risk of stroke from blood clots that form in the left atrial appendage (LAA), a pouch in the heart. By closing off this pouch, doctors help reduce the risk of stroke. The problem is that the Lariat device has never been tested or approved for LAA closure. Patients should be aware that the FDA has approved other devices specifically for LAA closure.
In July 2015, the FDA issued a Safety Alert to warn about six patient deaths and 45 serious adverse events linked to the Lariat device used in “off-label” LAA closure procedures. Three out of four patients had to have emergency open heart surgery.
What is the problem?
The Clark Firm, LLP is nationally recognized as a class action law firm in Texas. However, at this time our attorneys are not pursuing justice for our clients through a Lariat device class action. Instead, we are filing individual lawsuits against SentreHeart and only accepting cases involving serious injures.
Lariat Device LAA Closure Side Effects
- Heart laceration and/or perforation
- Bleeding (hemorrhage)
- Pericardial effusion (fluid collection around the heart)
- Cardiac tamponade
- Fluid collection around lungs