A new lawsuit has been filed against Argon Medical Devices Inc. and Rex Medical, L.P. over their Option retrievable inferior vena cava (IVC) filter that tilted and fractured.
Permanent IVC filters have been in use since the 1960s with few complications. However, retrievable IVC filters have a high rate of failure. Potential complications from retrievable IVC filters include device fracture, migration, and perforation of the inferior vena cava, which can lead to embolism, organ damage, and death.
The Daily Hornet reports that a lawsuit filed by Tamari W. from Philadelphia, Pennsylvania, claims she was injured when her IVC filter failed. On Jan. 19, 2015, an IVC filter was inserted into the vena cava, the largest vein in the body, via minor surgery by Dr. Jeffery Weinstein at Albert Einstein Healthcare Network. The purpose of the filter was to prevent a pulmonary embolism, a deadly condition in which a blood clot reaches the lungs.
Ten months later, Tamari had a CT scan of her chest. The results revealed that a wire leg of the filter had fractured away and had speared into the left hepatic lobe of her liver. A second fractured leg was found, still trapped inside the inferior vena cava.
Tamari was scheduled for surgery the very next day, but the attempt to remove the IVC filter was unsuccessful. A venogram revealed that the Option filter had not only tilted, but had also fractured into many smaller pieces.
On Nov. 19, 2015, an abdominal CT scan revealed two broken filter pieces in Tamari’s liver and her vein. The next day, she underwent another surgery to remove the IVC filter. It was unsuccessful, as well. At the time, Tamari was overwhelmed by the pain from her surgeries and the anxiety in relation to the failed filter.
Doctors made one more attempt to retrieve the filter, and were finally successful.
The lawsuit accuses Rex Medical and Argon Medical of negligence for not adequately testing the Option IVC filter, which would have ensured safety and efficacy. Through thorough testing, the medical device manufacturers likely would have detected an issue with device retrieval, the lawsuit claims.