TigerPaw Recall for Heart Tissue Damage Risks
Following Reports of Multiple Injuries and One Death, the FDA Announces Class I Recall for TigerPaw System II Over Potential Heart Tissue Damage Risks
The TigerPaw II is an implantable Left Atrial Appendage (LAA) occlusion device meant for use during cardiac surgery. The device is a surgical staple used to close tissue in the LAA of the heart. According to the Cleveland Clinic, the LAA is a small, ear-shaped sac located in the muscle wall of the left atrium, which is the top, left chamber of the heart.
The personal injury attorneys at Parker Waichman LLP are investigating the association between the recalled TigerPaw System II and heart damage and/or death and are also investigating potential lawsuits. If you, or someone you love, underwent a cardiac procedure with the recalled TigerPaw System II and suffered cardiac tissue damage or death, our personal injury attorneys would like to hear from you.
The TigerPaw System II
According to the Cleveland Clinic, it is unclear what, if any, function, is performed by the LAA. What is known is that, in normal hearts, contraction occurs in collaboration with every heartbeat, pressing blood in the left atrium and LAA into the left ventricle, which is the bottom, left heart chamber. In patients diagnosed with fibrillation of the heart, the electrical impulses controlling heartbeats do not move appropriately through the heart. When this occurs, many electrical impulses begin simultaneously, spreading through the atria. The disordered impulses do not enable the atria to appropriately and effectively contract or move blood into the ventricles. The LAA is a small pouch into which blood may collect, which enables the formation of clots in the LAA and atria. When clots are pumped out of the heart, a stroke may occur. In fact, individuals with atrial fibrillation (AFib) are 5 to 7 times likelier to suffer a stroke when compared to the general population.
Individuals at risk for developing clots in the left atrium/LAA may be considered candidates for a procedure in which the LAA is sealed to ensure risk of stroke is eliminated, along with the need for blood thinner drugs.
What is A Fib?
A fibrillation of the heart is the most common type of irregular heartbeat and, according to the American Heart Association, the most common symptom of heart AFib is a "quivering or fluttering" heartbeat. AFib is the abnormal firing of electrical impulses, which cause the heart’s top chambers—the atria—to fibrillate, which may feel like a quivering.
While some people with AFib do not experience any symptoms and are only diagnosed with a physical examination, other people may experience any of the following AFib symptoms when their heart is in fibrillation:
- Chest pain or pressure: THIS MAY INDICATE HEART ATTACK—SEEK IMMEDIATE MEDICAL ATTENTION
- Fatigue when exercising
- Fluttering, "thumping" in the chest
- General fatigue
- Rapid, irregular heartbeat
- Shortness of breath
Surgical Treatment for Atrial Fibrillation
The Cleveland Clinic notes that, surgical AFib treatment is considered when other heart fibrillation treatment options have been unsuccessful, such as when medical therapy is not effectively controlling or correcting atrial fibrillation; when prescribed medications are not tolerated; when the patient is unable to take anticoagulant medications, such as Coumadin (sarfarin); or when the patient has been diagnosed with blood clots, including stroke.
Minimally invasive surgery is an option for patients diagnosed with atrial fibrillation. Surgical treatment for atrial fibrillation may be a potential option when heart fibrillation surgery is needed to treat a coexisting heart condition.
FDA Announces Class I Recall of the TigerPaw System II
On May 7, 2015, the U.S. Food and Drug Administration (FDA) announced a recall of the Tiger Paw System II by Maquet Medical Systems. The recall was designated as a Class I Recall, its most serious designation. The Tiger Paw System may not close completely, resulting in tears and bleeding in the heart tissue, including a potential tear on the left atrial wall during use of the device.
Maquet Medical Systems, on behalf of Laax, Inc., issued an "Urgent Medical Device Recall (Removal) Immediate Action Required" letter, dated March 30, 2015, to all affected customers and advised that inventory be immediately examined for any recalled TigerPaw System II devices and to remove, quarantine, and place the recalled devices in a secure location. The affected devices were distributed from April 1, 2013 through March 23, 2015.
As of March 30, 2015, Maquet Medical Systems received 51 reports of adverse events and one death associated with the Tiger Paw system.