Inferior vena cava (IVC) filters are a life saver for some, a life threat for others. The devices are cage-like in appearance, with metal wire legs that are meant to catch a blood clot before it reaches the heart or lungs. The filter is deployed using a sheath that is inserted into the largest vein in the body, the vena cava.
Previously, IVC filters were permanent for the most part, used primarily in patients who could not tolerate anticoagulation medication. Medical device manufacturers such as C.R. Bard, Johnson & Johnson’s subsidiary Cordis, and Cook Medical have created a cheaper model intended to be temporary. The design has proven to be a risky one. Often the filter tilts, fractures, perforates, and migrates in the patients’ bodies.
Since the creation of temporary IVC filters, the number of injuries and deaths have increased exponentially. The Recovery filter by Bard has been linked to at least 27 deaths and hundreds of non-fatal injuries. Hundreds of lawsuits, more than 900 against Bard alone, have been filed as a result of the injuries and deaths that are blamed on the flimsy filters.
For one patient, according to an adverse event report filed with the FDA last March, the Bard G2X IVC filter resulted in a life-threatening experience.
“On two different dates last year, outside hospital images showed migration of the IVC filter,” the report reads. “The filter apex was found to be severely tilted and embedded along the wall.”
The report continues to detail at least three filter arms that had broken off and embolized into the pulmonary artery branches. The patient, at the time, no longer needed the filter, as the risk of venous thromboembolism (VTE) had already passed. However, the report states, during the attempt to remove the IVC filter using the instructed technique from the manufacturer, two additional filter legs were found to have fractured, one of which embolized into the right ventricle of the heart, and traveled through to the pulmonary artery.
Source: Medsun Report