According to an FDA Medsun report, a patient was being inserted with a Denali inferior vena cava (IVC) filter, made by C.R. Bard, when a fragment broke away.
An IVC filter is a device that resembles a spider. It is inserted into the largest vein of the body, the vena cava, and is designed to prevent pulmonary embolism by catching blood clots before they reach the heart or lungs. Around 1,500 lawsuits have been filed against IVC filter manufacturers alleging their tendency to tilt, migrate, perforate, or fracture.
The IVC filter was being inserted using the provided sheath for placement. When the sheath was pulled back to leave the device in position, providers noticed that a filter arm broke free. The fragment traveled through the veins to the heart, where it passed through successfully, but lodged in the left lung.
According to the report, the providers appropriately placed the device, confirming its correct position by CT scan that showed the size of the inferior vena cava and the location of the renal veins. The providers had to make a difficult decision: to leave the fragment behind permanently. They determined the risk of cardiac arrhythmias, hemorrhage and pulmonary embolism was too great to remove the IVC filter fragment from the patient’s lung.
C.R. Bard, along with many other medical device manufacturers such as Cook Medical, Rex Medical, and Johnson & Johnson’s subsidiary Cordis, are under scrutiny related to their removable IVC filters, which are intended to be left in the body only temporarily. The Recovery filter, now recalled, has been linked to at least 27 deaths and hundreds of non-fatal injuries.