Texas Lariat Suture Device Lawyer

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When the Lariat Suture Device is used in “off-label” heart surgery to prevent stroke, it can lead to severe complications or even death. The FDA has recently warned about 45 serious adverse events, including six deaths and dozens of emergency open heart surgeries.

What is the Lariat Suture Device?

The LARIAT® Suture Delivery Device made by SentreHEART, Inc. is a snare-like device that is approved by the FDA to deliver a pre-tied stitch (suture) to close soft-tissues during surgery. It is frequently used for unapproved, “off-label” surgeries to close off a pouch in the heart known as the left atrial appendage (LAA), which is believed to be the source of blood clots that cause strokes in patients with irregular heart rhythm (atrial fibrillation).

What is the problem?

No studies have evaluated the safety or effectiveness of using the Lariat Suture Device for LAA closure. It is not approved by the FDA for this purpose. An increasing number of adverse events suggest this procedure carries significant risks, including death.

FDA Safety Warning for Lariat Suture Device LAA Closure

July 13, 2015 — The FDA has issued a Safety Communication after receiving 45 reports of serious injuries and deaths associated with LAA closure procedures with the Lariat Suture Delivery Device. Of those events, 75% of patients had to have emergency open heart surgery.

Adverse events linked to Lariat Suture Device for LAA closure:

  • Six patient deaths
  • Laceration and/or perforation of the heart
  • Complete LAA detachment from the heart
  • Bleeding (hemorrhage)
  • Low blood pressure (hypotension)
  • Fluid collection around the heart (pericardial effusion)
  • Fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade)
  • Fluid collection around the lungs

Study Questions Safety of LAA Closure With Lariat Device

A study published in JAMA Internal Medicine has found that 2.3% of patients required emergency heart surgery after they were treated with the Lariat device for LAA closure. One patient died.

Lariat’s Regulatory Approval Loophole?

The Lariat device was approved under the 510(k) system, which allows new devices on the market without requiring safety studies so long as the device is similar to an existing device. The manufacturer claimed the Lariat was similar to ordinary, low-risk suture devices.

According to Heartwire, the Lariat appears to have been specifically designed for off-label use in the heart, but the FDA did not have any data supporting this use when it was approved. According to one expert:

“When you get into the weeds of it, the Lariat device appears to have been designed solely for the purpose of LAA exclusion. Upon 510(k) clearance, US and global patents were rapidly filed for closing the LAA with the device. The company even emphasizes ‘heart’ in its name.”

Is there an alternative?

In March 2015, the FDA approved Boston Scientific’s Watchman Device specifically for closure of the LAA in patients at risk of stroke due to atrial fibrillation.

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