watchman device lawsuit

Researchers highlighted the importance of their study, saying “… little is known about the outcome of patients with device emobolization, the anatomical location of [the] embolized device and the methods for device retrieval.”. By Todd Neale May 14, 2018 BOSTON, MA—Patients who develop thrombus on the Watchman left atrial appendage (LAA) closure device (Boston Scientific) carry a greater risk of stroke or systemic embolism, and there are hints of a causal relationship, a new analysis shows. In July 2016, the American Heart Association published a study in the journal Circulation: Cardiovascular Quality and Outcomes indicating devices like the Watchman were associated with “high rates of procedure-related harms.”. Watchman and other innovative devices like it have been touted by cardiologists as game changers in managing atrial fibrillation. The Watchman device has only been on the market for a short time, so all of the potential adverse events associated with the device are not yet known. The Watchman Left Atrial Appendage (LAA) Closure Device is a cage-like device used to prevent blood clots from traveling to the brain and causing a stroke in people with a heart condition called non-valvular atrial fibrillation, or AF. The manufacturer intended the device to prevent strokes in these patients while avoiding the dangers of uncontrolled bleeding … It is made up ofa metallic frame that is covered by a polyester mesh membrane.8 The metallic frame is made from nitinol, which is analloy of nickel and titanium that has unique memory andsuperelastic properties. Among many other things, a physician who implants a Watchman anti-stroke device must: Watchman stroke device insertion complications include: Watchman device insertion complications can lead to life-threatening injuries or death. In the PREVAIL trial, the Watchman was noninferior to warfarin for ischemic stroke prevention or systemic embolization after seven days, one of two co-primary end points for efficacy. Here is the problem: The Watchman device does not prevent strokes. WY: The Wyoming State Bar does not certify any lawyer as a specialist or expert. New device effective in preventing blood clots, but experts fear overuse, high costs Some health care experts fear technology will be used 'off-label' and drive up costs with no benefit It’s a permanent device that doesn’t have to be replaced and can’t be seen outside the body. The Watchman is permanently implanted in this pouch to create a seal and prevent blood clots from traveling to the brain. In fact, the Watchman has … Increase in Babies Born to Opioid Addicted Mothers, FDA Restricts Sales of Essure Birth Control Devices, The Opioid Epidemic’s Hidden Hospital Costs, Allegheny County’s Opioid Overdose Deaths, Official Allegheny County 2017 Drug Deaths, Opioid MDL Formed for Federal Opioid Cases, Plaintiff Wins Philadelphia Xarelto Bleeding Trial, Phila Jury to Deliberate in Xarelto Bleeding Trial, Watchman Left Atrial Appendage Closure Device, breakage and movement of the device after it has been implanted, and, blockages in several areas of patients’ hearts, inadequate insertion instructions provided by the manufacturer, and, the time and practice required to learn how to safely insert the device, determine which of 5 device sizes is most appropriate for a particular patient, determine which type of access sheath is most appropriate for the patient, confirm that no blood clots currently exist in the patient’s left atrium and left atrial appendage, take steps to avoid introducing air bubbles (emboli) during insertion, take steps to recapture partially or fully implanted devices when not safely inserted, embolization of the device during implantation (movement from the intended site that results in a blockage in the patient’s heart), breakage of the metal device during insertion, air bubble in a vein or artery (air embolism), pericardial effusion (excess fluid around the heart). Call the experienced lawyers at National Injury Help today for a free consultation to see if you qualify for a Watchman stroke device claims lawsuit. The FDA classified the September 2015 recall as a class II, meaning temporary or reversible adverse health effects were possible. During the company’s PROTECT AF trial, 9.9% of patients experienced a safety event during the first half of the trial compared to 4.8% during the second half. Five-year results of the PREVAIL trial, which compared the Watchman device with warfarin, were presented at the TCT 2017 and published in the Journal of the American College of Cardiology. Nothing contained in this website is to be taken as legal advice or opinion. Studied cases indicate that Watchman stroke devices can cause serious injuries due to: Watchman stroke devices can cause serious injuries even before the completion of device implantation. Once a patient’s Left Atrial Appendage is measured, a wide-sheathed catheter with a spline is used to insert the Watchman device which has a self-expanding Nitinol (a special metal) open-ended circular frame. The FDA-determined cause of the recall was “use error.” Boston Scientific said it initiated the recall because blood leakage could occur if implanting surgeons tightened the hemostasis valve with the dilator in place. Not available in all states. However, researchers also found case of late embolization. Theframe has 10 fixation anchorsthat allow it to anchor insidethe LAA chamber.8 The meshmembrane … This could suggest those complications did not arise from implantation errors. Call National Injury Help today to speak with a member of our legal team. Confidential or time-sensitive information should not be sent through this form. What are the risks of the Watchman implant? The device is intended to remain inside a patient’s heart permanently. On September 15, 2015, Boston Scientific initiated a class II recall of its Watchman device and access sheath, which helps guide the Watchman into the heart. Some of these adverse events occur because of the device itself, while others can occur during the implantation procedure. In this 5-year follow-up, outcomes with the Watchman LAAC device and warfarin were largely equivalent. The Watchman device comes in multiple sizes from 21mm to 33mm to accommodate the different sizes of LAAs. Device-related thrombus mitigates the benefits of LAA closure relative to warfarin, but not relative to doing nothing at all, one expert says. There may be substantial cash awards from lawsuit settlements for this Boston Scientific device. Boston Scientific's stroke-preventing Watchman was just hit by bad news on multiple fronts. If you are visiting any of our drug pages please note: The FDA approved this medication after it determined that the benefits of the product outweigh the known risks for the intended use. Did you suffer serious complications or side effects after having a Watchman stroke device implanted? This may be due to: In 2015, Boston Scientific recalled nearly 30,000 of the devices after reports of injuries sustained during the device’s insertion. The Watchman device has been linked to serious adverse health consequences, including migration of the device, fracture of the device, damage to heart valves and the potential need for additional surgeries due to complications. This site does not provide legal advice. The device may cause a clot to form and move into your bloodstream. The cases indicated most of the embolizations were acute, or occurring shortly after implantation. Before you decide, ask us to send you free written information about the qualifications and experience of our sponsoring firms. This may suggest complications arose because of implantation errors during the initial surgery. If you or someone you love was injured as a result of having the Watchman device implanted, you may be entitled to compensation. We can answer your questions and help you determine if your case qualifies for a possible Watchman Lawsuit. Individuals harmed by the Watchman LAA Closure Device may be able to seek settlements in the form of a Watchman Lawsuit. DO NOT STOP TAKING THIS MEDICATION OR ANY PRESCRIBED MEDICATION WITHOUT CONSULTING WITH YOUR PHYSICIAN FIRST. The hiring of a lawyer is a very important decision that should not be based solely upon advertisements. These properties of nitinol allowthe Watchman device to configure to the contours of theLAA after deployment. 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