According to Medsun Reports from the U.S. Food and Drug Administration (FDA), a patient with a history of chronic deep vein thrombosis and pulmonary embolus received a Bard G2X inferior vena cava (IVC) filter and two Celect filters, all three of which failed. The patient went into cardiac arrest and passed away.
After the patient was inserted with a Bard G2X filter, he was admitted to the hospital a year later with chest pains. A heart catheter showed that the coronary artery looked normal, but resulted in “incidental finding” of a fractured leg of the filter in the patient’s right ventricle.
Using interventional radiology, the fragment was successfully retrieved, but the attempt to retrieve what was left of the filter itself failed. A second attempt to retrieve the filter was scheduled.
The patient, however, returned to the hospital about six weeks later with shortness of breath. His diagnosis included pulmonary embolism and pulmonary artery thrombus, and doctors discovered that the G2X filter had tilted. Another attempt to remove the G2X filter was unsuccessful, and revealed a large thrombus caught in the legs of the filter, increasing the risk involved in filter removal.
A second IVC filter, the Celect by Cook Medical, was inserted. Several more attempts to remove the G2X filter were required, using both the snare retrieval system and endobronchial biopsy forceps before the G2X filter was finally removed, luckily, intact.
During the procedure, however, the Celect filter became tilted, and several attempts to retrieve it failed. A second Celect filter was inserted at that point. The patient developed severe shortness of breath and hypotension, went into a cardiac arrest, then passed away.
The unfortunate death of this patient is one of many involved in the controversy over the use of retrievable IVC filters. Device makers such as C.R. Bard and Cook Medical currently face a number of lawsuits alleging injuries and death linked to filters that have migrated, fractured or tilted inside the body after they have been inserted.