FDA Issues Class I Recall of TigerPaw II Left Atrial Appendage Occlusion Device Amid Reports of Atrial Tearing and Bleeding

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FDA Issues Class I Recall of TigerPaw II
FDA Issues Class I Recall of TigerPaw II

FDA Issues Class I Recall of TigerPaw II
FDA Issues Class I Recall of TigerPaw II

The TigerPaw II Left Atrial Appendage (LAA) occlusion device, a surgical staple used to close tissue in the LAA of the heart, has been recalled by the U.S. Food and Drug Administration (FDA).

The agency issued a Class I recall of the TigerPaw II amid reports that the device could tear the left atrial wall and cause bleeding. A total of 4,154 of the devices are affected by the recall. The FDA labeled the recall a Class I recall, which means there is a reasonable likelihood or serious adverse health consequences or death associated with the use of the device in question.

The TigerPaw II is a single-use delivery tool and implantable fastener used to seal the LAA. Occlusion of the LAA is intended to reduce the risk of postoperative stroke caused by atrial fibrillation (afib), but the TigerPaw II may actually contribute to strokes. According to the Cleveland Clinic, it’s clear what, if any, function is performed by the FAA. In normal hearts, contractions occur alongside each heartbeat, pressing blood in the left atrium and LAA into the left ventricle, which is the bottom, left heart chamber. In afib patients, the electrical impulses that control heartbeats do not move properly through the heart, resulting in many electrical impulses beginning simultaneously and spreading through the atria. The disordered impulses prevent the atria from appropriately and effectively contracting or moving blood through the ventricles. The LAA is a small pouch that may collect blood, allowing clots to form. When these clots are pumped out of the heart, a stroke may occur. Patients with afib are five to seven times more likely to suffer a stroke compared with the general population.

Maquett, on behalf of Laax, Inc., first issued an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter to all affected customers on March 30, 2015, advising that inventory should be immediately examined for any recalled devices, and any affected TigerPaw II systems should be removed, quarantined and placed in a secure place. The affected devices were distributed from April 1, 2013 through March 23, 2015. As of March 15, 2015, Maquett had received 51 reports of adverse events and one death associated with the LAA occlusion device.

The TigerPaw II system was approved under the FDA’s 510(k) pathway, which allows a device to be approved by the agency if it is significantly similar to another product already on the market. No clinical data testing is required.