W&L has begun looking into the dangers of using the TigerPaw System II during occlusion of the heart’s left atrial appendage, a procedure sometimes performed in patients with atrial fibrillation to prevent blood clots from collecting and traveling to other parts of the body.
The firm has discovered reports regarding the closure device reported in the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. We are investigating injuries sustained due to the potential for this device to cause tearing of cardiac tissue and/or bleeding.
LAAx, Inc.’s voluntary recall of its TigerPaw System II implantable occlusion fastener was initiated on March 25, 2015. On April 23, following the company’s voluntary recall, FDA designated this a Class I recall. The FDA Recall Notice states that the TigerPaw System II device may cause problems, including tears and bleeding in the heart tissue.
At the time of the FDA’s Class I recall designation, the MAUDE database contained several reports of dangerous incidents involving the device, including bleeding that prolonged surgery times and one death.
LAAx, Inc., the developer of the 510(k) device, on behalf of Maquet Medical Systems, sent an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter to all affected customers, requesting them to remove, quarantine, and place recalled devices in a secure location.
FDA Designates Class I Recall of TigerPaw System II Due to Possible Cardiac Tearing and Bleeding
The FDA designated the TigerPaw System II a Class 1 recall, including 4,154 devices distributed in the United States, due to the risk of tears and bleeding in the left atrium linked to the possibility of incomplete closure of the device. A Class 1 recall is the most serious level of recall, “in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The TigerPaw II was approved by the FDA in May of 2011 for occlusion of the left atrial appendage. It is intended to be used in cases of left atrial appendage occlusion when the doctor can directly see the heart (known as direct visualization), without the use of camera or other devices used for viewing anatomical structures.
When implanted during heart surgery, the TigerPaw System II was indicated to seal the left atrial appendage (LAA), a small sac located in the top left chamber of the heart.
The device’s intended purpose was to bind itself to this small sac so that blood could not collect in this area and form clots. This complication is common when a patient has been diagnosed with atrial fibrillation, which is an irregular heart rhythm.
LAAx began distributing its TigerPaw System II in 2013. Maquet Cardiovascular LLC acquired LAAx in May 2013.
TigerPaw System II Patients Invited to Reach Out to W&L for Free Consultation
When manufacturers create devices designed to help patients, it is imperative that they operate correctly.
If you have been diagnosed with atrial fibrillation and have undergone heart surgery that included an LAA occlusion procedure within the last two years, W&L invites you to contact us with any questions or concerns you may have.
Depending on your circumstances, you could be entitled to reimbursement for the cost of corrective surgery, hospitalization and related medical services.
You may also be entitled to compensation for income lost while undergoing a corrective surgery and the period of time during which you were recovering from surgery and unable to work.
Other forms of compensation may be available also.
To arrange a free consultation, contact W&L by calling (800) 476-6070 or reach us online by using our form or live chat.