SILVER SPRING, MD — The US Food and Drug Administration (FDA) has issued a class 1 recall of the TigerPaw II (Maquet, Rastatt, Germany) left atrial appendage (LAA) closure device[1].
The recall was issued on April 23, 2015 following reports the device could cause tearing of the left atrial wall and bleeding, which the FDA says may or may not be caused by incomplete closure of the system's fastener. In total, 4154 TigerPaw II devices currently in distribution have been recalled. All hospital stock is to be removed, quarantined, and returned to the company.
The mechanical occlusion system consists of a single-use delivery tool and implantable fastener to occlude the LAA. The silicone fastener is designed to conform to the LAA anatomy and tissue thickness when it is placed on the ostium of the appendage. Occlusion of the LAA is intended to reduce the risk of postoperative stroke caused by atrial fibrillation.
The TigerPaw II is currently approved by the FDA for LAA occlusion in cardiac surgical procedures when the surgeon is directly able to see the heart without assistance from a camera, endoscope, or other viewing technologies (direct visualization).
The device is made by US-based LAAx (Livermore, CA), but the company was purchased by Maquet in 2013. The TigerPaw II has been commercially available in the US and Europe since 2013, while the original iteration of the device, the TigerPaw, was cleared by the FDA in 2010.
In contrast with the now-approved Watchman LAA closure device (Boston Scientific, Marlborough, MA), which was approved via the premarket approval (PMA) process in March 2015, the TigerPaw system was approved under the 510(k) pathway. The two systems differ, however, in that the Watchman is a transcatheter device approved for LAA closure, whereas the TigerPaw II is used in conjunction with open-heart surgery.
The FDA class 1 recall—the most serious of its kind because the agency deems there is a reasonable likelihood of serious adverse health consequences or death if the device remains on the market—affects TigerPaw II systems distributed throughout the US, as well as in Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, the Netherlands, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sweden, Switzerland, Turkey, and the United Kingdom.
Cite this: FDA Recalls TigerPaw II LAA Closure Device - Medscape - Apr 27, 2015.
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