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On March 30, 2015, LAAx, Inc. and Maquet Medical Systems issued a voluntary recall of the TigerPaw System II left atrial appendage fastener. This device is intended for use in open heart surgery to seal a small sac in the upper left chamber of the heart called the left atrial appendage (LAA).
On April 23, the FDA categorizing this recall as a Class I recall, saying that “[i]ncomplete closure of the TigerPaw System II may result in tissue tears and/or bleeding, including a possible tear on the left atrial wall (top left chamber) during use of the device.” The FDA’s recall notice states that Maquet Medical Systems received 51 reports of adverse events regarding the TigerPaw System II device and one report of a patient death.1
Recall Means Device May Be Life-Threatening
An FDA Class 1 recall is the most serious type of recall. A recall of this level means that “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” The recall of the TigerPaw System II surgical fastener affects approximately 4,150 devices distributed in the United States. 2
On March 30, LAAx, Inc. sent an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter to all affected customers. The letter instructed customers to examine their inventory to determine if they had any TigerPaw System II recalled devices, to remove the products, quarantine them, and place them in a secure location.1 3
Developed by LAAx, Inc., the TigerPaw System II was distributed from April 1, 2013, through March 23, 2015. Maquet Medical Systems, located in Rastatt, Germany, acquired LAAx, Inc. in 2013. 4
MAUDE Database and TigerPaw System II Adverse Events
A search of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database found several reports of TigerPaw System II adverse events.
In one incident, a patient died following a heart surgery in which a tear in the atrium occurred immediately after the TigerPaw System II device was implanted. Although the surgeon repaired the immediate damage, the patient suffered from hemorrhagic shock and later developed sepsis, and died from kidney and liver failure. The cardiac surgeon that performed the procedure stated that the application of the TigerPaw System II “created an unusual tension at the atrium, causing the laceration and all subsequent events.”
Other reports describe similar bleeding and tears. 5
TigerPaw System II Is Used in Open Heart Surgery
The TigerPaw System II is a surgical fastener implanted during open heart surgery, often to treat patients diagnosed with atrial fibrillation, an irregular, unnatural heart rhythm. When inserted, this device was indicated to seal a small sac located in the top left chamber of the heart called the left atrial appendage (LAA). 3 4
Occlusion of the left atrial appendage is performed to prevent blood from pooling in this area and forming clots, a common complication of atrial fibrillation. This complication can be serious because clots could travel through the heart to the brain, resulting in a stroke.4 7 6
FDA Approved TigerPaw System II Through 510(k) Process
The FDA approved the TigerPaw System II device in 2011 after LAAx Inc. submitted an application through the agency’s 510(k) process. This procedure allows a manufacturer to introduce a new product to consumers after demonstrating that the device is at least as safe and effective, or “substantially equivalent,” to another 510(k) device that has already received FDA approval 8 9