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In April 2013, Cordis Corporation, a subsidiary of Johnson & Johnson, sent an urgent medical device correction letter to customers in the United States and Canada to provide updated labeling on their retrievable OptEase IVC filter. The letter clarified implantation procedures for doctors to decrease the risk of implanting the device upside down. Several months later, the FDA declared this letter constituted a Class I recall, the most serious recall the FDA issues. The recall covered 33,000 IVC filter devices implanted between May 6, 2010 and April 2, 2013. While their retrievable OptEase IVC filter faced an increased risk of incorrect orientation, the company’s permanent TrapEase IVC filter came under fire for the increased risk of device fracture.
Inferior vena cava filters (IVC filters) are medical devices that are placed in a patient’s inferior vena cava to prevent pulmonary embolisms by catching any blood clots that try to migrate into the lungs. IVC filters are used in patients that cannot safely tolerate other methods of blood clot prevention like anticoagulants. Cordis OptEase IVC Filters, like many types of IVC filters, are only meant to be implanted temporarily, and should be removed after the risk of pulmonary embolism has sufficiently decreased. Failure to remove the device greatly increases the risk of the patient developing serious complications.
While all IVC filters pose risks, prior to its 2013 recall, the OptEase Retrievable IVC Filter manufactured by Cordis posed a serious threat to patients due to inadequate labeling. A printing error on the device’s labeling included an arrow that was pointing the wrong direction, causing many doctors to insert the device upside down. While there are fixation barbs on the device designed to hold it in place, when placed upside down, there is no resistance to prevent the device from migrating into the heart.
The TrapEase IVC filter proved to be no better when a 2011 study found the TrapEase to have a higher fracture rate. Fractured pieces of the device often migrate to other parts of the body and can embed themselves into a patient’s heart, lungs, or other organs. Incorrectly oriented or fractured IVC filters have to be removed from patients to prevent further complications; but, removing the filters also pose a serious risk as the devices have to be removed via a jugular approach, contrary to their insertion, because the devices have hooks that could easily snag and cause complications.
If you or someone you love had a Cordis IVC Filter implanted and suffered additional complications from incorrect orientation or fracturing, you may have the ability to file an IVC filter lawsuit. Contact the experienced defective medical device attorneys at Raizner Slania to evaluate your claim and protect your legal rights.