According to a U.S. Food and Drug Administration (FDA) complaint report, a Bard G2X IVC filter implanted into a patient six years ago was found to have severely migrated.
An IVC filter is a cage-like device inserted into the inferior vena cava, the largest vein in the body. The filters are designed to catch blood clots and are used often in patients that cannot tolerate anticoagulation medication. But the devices, particularly temporary models, have been known to migrate, tilt, and perforate the vein and other organs. They’ve also been known to fracture, sending metal filter arms throughout the patient’s body.
On two different dates last year, the patient’s hospital images showed the device migrating from the infrarenal inferior vena cava (IVC), which is below the kidney, to the anterior IVC atrial junction, which is the front divided right atrium of the heart. The filter itself was “severely tilted” and had embedded in the wall of the vein. At least three fractured filter arms had embolized into the pulmonary artery branches.
The patient underwent complex IVC filter removal, both to prevent further complications from the shattered device, and because the filter was no longer necessary, as the patient had experienced a full recovery from acute blood clot formation in the vein (VTE).
While the filter was being extracted, one of the three filter arms embolized into the right ventricle of the heart, then traveled to the pulmonary artery, nearly causing the patient to experience a filter-induced pulmonary embolism.
IVC filter manufacturers such as C.R. Bard, Rex Medical and Cook Medical are facing more than 1,500 lawsuits for injuries and deaths linked to the filters.