What the hospital X-ray showed was alarming.
Two small metal tines had broken away from a small medical device that had been inserted into her vena cava (body’s largest vein) to prevent blood clots after an orthopedic surgery she had 2008 to correct problems with an ankle after a fall at work.
The doctors found one of the broken tines had poked a hole in her pericardium (the fibrous sac around the heart) and pierced her heart muscle. The bleeding inside her chest was profuse. Without immediate surgery to remove the tine and repair the puncture the injury could have caused death.
The IVC filter with the broken tines was a C.R. Bard G2 IVC retrievable filter.
The IVC retrievable filter is a type of medical device manufactured by several different companies. It is designed to literally trap blood clots before they reach the heart or lungs and cause strokes or pulmonary embolisms in the lungs.
It’s estimated that as many as 250,000 of these types of devices are inserted into patients every year. They are often used in people who have orthopedic surgery or gastric surgery to prevent clots. However, they are used primarily for people who cannot take blood thinners such as Warfarin or Coumadin. Protocol says IVF retrievable filters can be removed or left in the vena cava for long periods of time.
Attorney Buck Daniel, from the Howard Nations firm, represents the Atlanta nurse in personal injury suits filed against C.R. Bard, the manufacturer of the Bard Recovery IVC retrievable filter which is still making its way through the courts.
“The doctor showed her husband an X-Ray that day with the piece of the IVC Filter that had broken away,” says Daniel. “They pulled the tine out with forceps. If that tine had stayed in there much longer without the hole being closed she could have bleed to death,” he says.
Now three years after the San Francisco event Daniel’s client is back at work. Doctors never found the second tine. It is still somewhere in her body.
“So, she lives that fear every day that the missing tine will do what the other one did,” says Daniel.
Buck Daniel and the Howard Nations firm represents about 1,000 people in similar personal injury suits against C.R. Bard involving IVC filters.
Beginning in the early 2000s problems the IVC retrievable filters began to emerge. The metals tines, or struts, break off sometimes embedding themselves in nearby tissue or organs, sometimes migrating through the blood stream, even perforating the heart. Sometimes they simply slip out of place and stop blocking blood clots.
In FDA has issued two warnings letters regarding IVC retrievable filters, first in 2010 and then again in 2014.
READ MORE IVC FILTER LEGAL NEWS
There are now two MDL cases going forward in the US involving hundreds of litigants – one is consolidated in Arizona and the other is consolidated in Indiana. In addition there are dozens of individuals suits filed across the country. Bell weather trials are expected this year.
The three main manufacturers are C.R. Bard, Cook Medical and Boston Scientific. The main products are the Bard Recovery filter, the Bard G2 filter, the Bard G2 Express filter, the Cook Gunther Tulip filter, Cook Celect filter and the Boston Scientific Greenfield filter.