No Longer Accepting Cases

May 7, 2015 — The FDA has issued a Class I recall for the TigerPaw System II, a snare-like device used to close off a sac in the heart believed to be the source of blood clots that cause strokes in patients with atrial fibrillation.

The FDA has received 51 reports of adverse events and one death. These reports involved tearing of the left atrial wall and bleeding. According to the FDA, these events could be caused by incomplete closure of the device’s fastener.

The TigerPaw System II is a surgical staple system used in open-heart surgery. It is approved by the FDA for the closure of the Left Atrial Appendage (LAA), which is intended to reduce the risk of post-operative stroke. It is only supposed to be used when the surgeon can directly see the heart.

Study Raises Concerns for Lariat LAA Closure Device

Earlier this week, JAMA Internal Medicine published a study questioning the safety of the Lariat device for LAA closure.

The Lariat was approved through the 510(k) approval process, which allows manufacturers to sell new devices without conducting new safety studies so long as it is “substantially equivalent” to another device on the market.

The Lariat is widely-used “off-label” for LAA closure, but no comprehensive studies have investigated its safety. Out of 309 procedures, 90% were successful but seven individuals (2.3%) required urgent cardiac surgery and one patient died.

According to Heartwire the Lariat device appears to have been designed solely for the purpose of LAA closure, noting that the manufacturer even emphasizes the word “heart” in its name. However, the FDA did not have any data supporting its use in heart surgery when the device was approved.