An IVC filter, or inferior vena cava filter, is a small basket-like device used to prevent blood clots that are loose in the bloodstream from traveling from the lower body up to the lungs, where they can cause a potentially fatal pulmonary embolism.

These devices see frequent use in patients who are at risk for pulmonary embolism but for whom anticoagulant medication is not a good option.

The filter is placed inside the inferior vena cava, the large blood vessel that runs from the legs to the upper body.

Patients who require long-term protection from pulmonary embolism may be implanted with a device designed to be permanent.

Other filters are designed to be retrievable once the patient is no longer at risk for pulmonary embolism.

Problems may arise when an IVC filter fails – and some research suggests that even normal movement of the inferior vena cava may be enough to cause IVC filter failure.

Cases of IVC filter failure have been documented in which the device fractured or came detached from the wall of the inferior vena cava, allowing its parts or the entire device to migrate elsewhere throughout the bloodstream.

As a result of IVC filter failure, fragments of a filter can migrate all the way to the heart, putting the patient at risk for complications like arrhythmias or myocardial perforation.

In other cases, IVC filters perforated the walls of the inferior vena cava. Researchers say that while most cases of perforation are asymptomatic, it can lead to damage of the surrounding structures as extreme as aortic dissection or gastrointestinal hemorrhage.

FDA Warnings Address Risk of IVC Filter Failure

In August 2010, the FDA issued a communication addressing the complications associated with IVC filter failure. The agency expressed concern that filters designed to be only temporary were being left in place longer than necessary, exposing the patient to an unnecessary risk of IVC filter failure.

The agency recommended that these retrievable IVC filters be removed as soon as the patient was no longer in need of protection from pulmonary embolism.

In issuing this advisory, the FDA said it had received 921 reports of adverse events associated with IVC filters. These reports documented cases of device migration, detachment of device components, perforation of the inferior vena cava and fracture of the filter.

The FDA followed up with a new communication in May 2014. The agency updated its original 2010 advisory with the results of subsequent research, which suggested that in patients whose risk of pulmonary embolism had passed, “the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.”

Litigation Over IVC Filter Failure

Problems associated with IVC filters have led to a new wave of products liability litigation. Manufacturer C.R. Bard is facing the largest number of claims, with over 700 lawsuits implicating that company’s G2, G2 Express and Recovery IVC filters.

The federal court system has consolidated these claims into a single multidistrict litigation, or MDL, going on in a federal court in Arizona.

Not far behind is manufacturer Cook Medical, whose Celect and Gunther Tulip filters have drawn about 650 claims. These claims have been consolidated into a separate MDL pending in Indiana.

Over 100 other claims have also been filed alleging complications associated with other manufacturers’ filters.