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Celect 10 articles

Study Finds IVC Filters may Not Meet Safety and Effectiveness Criteria

In a recent study testing the safety and effectiveness of inferior vena cava (IVC) filters used to protect against pulmonary embolism (PE), researchers have concluded that the device fell short of criteria required to deem the device safe and effective. A pulmonary embolism is a severe condition that is often fatal. It occurs when a blood clot forms in a lower extremity and embolizes to the heart or lungs. Anticoagulation medication is used for treatment of recurrent embolism, but not all patients can tolerate the drugs. A vena cava filter is often used in place of anticoagulation medication. It is a ... Read More

Lawsuit alleges IVC filter breakage resulted in potentially life-threatening internal injuries

Joan Wiseman, a resident of California, filed a complaint in August against Cook Medical alleging the company’s retrievable IVC filter is a “defective medical device” that caused her internal injuries that could have been life-threatening. An IVC filter is a cage-like device implanted in the inferior vena cava, the largest vein in the body. Its purpose is to catch blood clots, preventing them from reaching the heart or lungs, particularly in patients that cannot take anticoagulation medication. Wiseman claims that the device used was defective. It was a Celect IVC filter, made by Cook, which has been under fire recently with more than 800 federal lawsuits in a Multi-District Litigation (MDL) alleging IVC ... Read More

Cook Medical’s initial attempts at settling IVC Filter litigation Fail

Hundreds of people who have filed legal claims alleging they have been injured by failed inferior vena cava (IVC) filters have been considering Cook Medical’s talks of settlements. However, U.S. Magistrate Judge Tim Baker and attorneys for both the medical device manufacturer and patients were unable to find common ground to reach a settlement. The meeting ended “without further order.” If the negotiations regarding the settlements fail, then the lawsuits filed by the patients claiming injury related to the IVC filters will go to trial. As of Aug. 15, the number of federal lawsuits in the Multi-District Litigation (MDL) against Cook Medical ... Read More

First bellwether trial in Cook IVC Filter litigation set for 2017

Cook Medical, Inc. has been in hot water lately over allegedly defective inferior vena cava (IVC) filters that have reportedly failed. More than 650 federal lawsuits are now pending in a multidistrict litigation (MDL) against the device manufacturing giant, and a judge has chosen the first bellwether case to go to trial in 2017. The case involves Florida resident Elizabeth Jane Hill who was given a Celect IVC filter in November of 2010. The Celect model is a retrievable IVC filter that the FDA recommends removing within 29 to 54 days after implantation. If the filter remains longer than recommended, the patient is at ... Read More

Study: IVC Perforation is ‘rule rather than exception’ for the Günther Tulip, Celect IVC Filters when not retrieved timely

At the University of California, San Francisco a study was conducted to test the “incidence, magnitude, and impact” of the ability for a retrievable inferior vena cava (IVC) filter to be retrieved, and the impact of timely retrieval. The Gunther Tulip and Celect model IVC filters, made by Cook Medical, were the chosen to be tested. Medical records were used to identify 272 filters placed between July 2007 and May 2009. When 50 of those patients received a follow-up CT scan unrelated to the IVC filter, all patients showed “some degree” of vena caval perforation, after the filter had been left in for 71 days. In 20 ... Read More

Doctors Discover 4.5 Centimeter Wire in Delaware Woman’s Chest; IVC Filter Fractured

On July 5, 2005, Bianca Fraser-Johnson received an inferior vena cava (IVC) filter at University of Pennsylvania Hospital in Philadelphia, Pennsylvania. The filter was a G2 retrievable model made by C.R. Bard, one not designed to be left in place for long periods of time. In July of 2013, Fraser-Johnson was living in Delaware when she began experiencing severe chest pain, and rushed to her doctor to be checked. On July 10, doctors removed a 4.5 centimeter wire from her chest, not knowing how the wire could have gotten there. In the spring of 2015, Fraser-Johnson experienced severe chest pain again, and ... Read More

Patient Dies after three Retrievable IVC Filters Failed

According to Medsun Reports from the U.S. Food and Drug Administration (FDA), a patient with a history of chronic deep vein thrombosis and pulmonary embolus received a Bard G2X inferior vena cava (IVC) filter and two Celect filters, all three of which failed. The patient went into cardiac arrest and passed away. After the patient was inserted with a Bard G2X filter, he was admitted to the hospital a year later with chest pains. A heart catheter showed that the coronary artery looked normal, but resulted in “incidental finding” of a fractured leg of the filter in the patient’s right ... Read More

New study reveals that educating doctors about IVC filters reduced usage

Last month, a study was published regarding physician’s education on the use of inferior vena cava (IVC) filters. The purpose of the study was to see if the physicians’ familiarity with IVC filter use, the current evidence of its efficacy, and guidelines on insertion and retrieval had any impact on the physicians’ use of the device, and the retrieval rates. The abstract for the study notes methodology involves “Fourteen continuing medical education-approved in-hospital grand rounds covering evidence-based review of the literature on IVC filter efficacy, patient-centered outcomes, guidelines for IVC filter indications, and complications were performed across a large United States ... Read More

Research reveals Main Cause of Inferior Vena Cava Thrombosis is an Unretrieved IVC Filter

Inferior vena cava thrombosis isn’t as common as deep vein thrombosis, but is equally as dangerous. It can cause a variety of symptoms, which may make it difficult to diagnose initially, but can often be detected with a CT scan. Treatment usually consists of surgical management, anticoagulation medication, and/or thrombolytic therapy. IVC blood clots can be caused by many things, such as tumors, inflammatory processes, or vessel injury due to trauma (from a car accident, for example). But the main cause of IVC thrombosis is surprising: unretrieved IVC filters. Dr. Mohamad Alkhouli from University of Rochester Medical Center, New York, told Reuters Health ... Read More

Lawsuits Against Makers of Defective Retrievable IVC Filters Consolidated to Southern District of Indiana

Lawsuits against Cook Medical, Inc., the maker of the retrievable IVC filter known for its allegedly defective design have been consolidated to Southern District of Indiana in a multidistrict litigation (MDL). The IVC filter is a cage-like device that is implanted into the largest vein of the body – the inferior vena cava – and is designed to catch blood clots, preventing them from entering the heart and/or lungs, resulting in pulmonary embolism. Retrievable designs, such as Cook’s Gunther Tulip or Celect filters, are intended to be used for a short period of time, then removed. They are often used in ... Read More