One of the devices commonly used during open heart surgery is a surgical stapler called the TigerPaw II. The primary purpose of this device is to close the tissue in the heart that has been opened during procedures to treat atrial fibrillation. In March of 2015, this system was recalled when it was discovered that the devices not only failed to perform the functions intended but may cause additional injury that can lead to serious complications or death. If you or a loved one elected to undergo a surgical treatment for atrial fibrillation and were injured during the procedure, you may be entitled to compensation due to medical negligence or product liability.
Rosenfeld Injury Lawyers LLC is actively involved with potential claims and lawsuits involving the TigerPaw surgical stapler. If you or a loved one suffered complications such as: internal bleeding, blood clots, uncontrolled bleeding, infection, heart failure, heart attack, stroke or death following a heart surgery, let our office investigate the matter for you without cost on your part. As with all of our medical device litigation, we work on a contingency fee basis where a fee is only charged when there is a recovery for you.
The Function of the TigerPaw System II
Atrial fibrillation is a condition that occurs when the upper chambers of the heart do not maintain a steady rhythm with each other. The primary complication that arises due to this condition is the formation of blood clots in the heart which can cause a heart attack or stroke. If you are a sufferer of this condition, you may have been placed on a blood thinning medication as a means of preventing these clots but blood thinners are the cause of another unique set of risks and complications so when your doctor deems it the best path forward, he or she may recommend surgery.
Prior to surgery, your doctor should consider all available options of treating atrial fibrillation. Cardioversion is often considered in advance of surgery as a means of resetting the heart’s rhythm and elimination the risk of blood clotting. If successfully, cardioversion can eliminate the need for blood thinners or surgery and can be attempted through a procedure in which electrical shocks are administered through the chest to momentarily stop and restart the heart. Alternatively, medications may be used in an attempt to establish a steady heartbeat. When these methods fail, prescribing blood thinners or suggesting surgery become the best remaining options.
If you are keen on the status of blood thinning medications such as Warfarin and Xarelto, you are already aware of the dangers associated with their use, so you may elect to undergo surgery. The purpose of the surgical procedure is to prevent the blood from having the opportunity to form clots within the upper two chambers of the heart. The left atrium is the most common area for clots to form so your surgeon would close the left atrial appendage during the procedure— using the TigerPaw System II to insert staples designed to close the area.
How Tiger Paw Surgical Staples Have Allegedly Harmed Patients
Reports began to surface that patients undergoing surgeries using the TigerPaw System II experienced serious complications and injuries to their hearts during the procedures. Among the adverse events were reports that the staples tore the atrial wall and caused significant internal bleeding. In other cases, the device failed to seal the left atrial appendage, which allowed blood clots to form, rendering the procedures ineffective. Concerns with the TigerPaw System II included the following.
- Internal bleeding due to tears in the atrial wall or at the site where the staples were placed.
- Formation of blood clots despite assertions that the procedure would prevent clots from forming.
- Infections caused due to bleeding or injuries incurred during the procedure.
- Heart failure due to bleeding or infection.
- Death brought on by the effects of any of the aforementioned complications.
FDA Announces Class I Recall of TigerPaw System II
The Class I designation given to a recall by the FDA indicates that the product is capable of causing serious harm. Most medical devices recalls receiving this classification are capable of causing debilitating or fatal injuries. As a result of the recall, Maquet Medical Systems has recalled over 4,100 of its TigerPaw System II devices and instructed surgeons to quarantine or remove the devices. All recalled systems are to be placed in a secure location until further notice.
It is anticipated that patients who underwent procedures prior to this recall may have valid claims against Maquet Medical Systems, which purposed the manufacturer of the device in 2013. To learn more about current cases being formed and how litigation may affect your own claim, contact Rosenfeld Injury Lawyers LLC for the up to the date information as well as to investigate your own matter to determine whether it is in your best interests to file a claim of your own.
Rosenfeld Injury Lawyers LLC has represented numerous clients in medical negligence and medical product liability claims and our success stems from our access to a team of experts in fields that are crucial to building your case, establishing its value and presenting it effectively in front of a jury. Arrange a risk free and confidential consultation with us today to learn how we can assist you by connecting you to the medical professionals most qualified to give you proper care and securing the compensation needed to pay for your care.