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FDA Issues Warning for IVC Filter Injuries

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The Food & Drug Administration (FDA) issued an alert today regarding complications with Inferior Vena Cava (IVC) filters. In the alert, the agency said it is concerned that retrievable IVC filters, intended for short-term placement, are not always removed.

Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients, the agency said.

The agency is encouraging all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated, the FDA said.

IVC filters are small, cage-like devices that are inserted into the inferior vena cava (the main vessel returning blood from the lower half of the body to the heart) to capture blood clots and prevent them from reaching the lungs. IVC filters are frequently placed in patients at risk for pulmonary embolism, or PE, when anticoagulant therapy cannot be used or is ineffective. Some patients may require long-term protection from PE, and implantation of permanent IVC filters is often performed in these cases. Others only require short-term protection, in which case retrievable IVC filters are typically used, as these devices have the option to be removed once the patient’s risk of PE subsides.

Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

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