Product News and Recalls

Bard singled out as problem IVC filter

According to the Wall Street Journal, the U.S. Food and Drug Administration has issued a warning about more than 900 reported problems from inferior vena cava, or IVC filters, meant to catch blood clots.

Although the FDA didn’t detail the number of reports by manufacturer, the Wall Street Journal says, a separate report published in the Archives of Internal Medicine found problems associated with two types of filters made by C.R. Bard.

The IVC filters are inserted into the main vessel returning blood from the lower half of the body. They’re used to treat patients with venous thromboembolism, or blood clots in the legs, and are meant to keep the clot from traveling to the lungs where it can sometimes be fatal.

According to the Wall Street Journal, researchers examined two types of Bard filters implanted in patients at York Hospital in York, Pa., after a patient suffered a perforation in the heart three years after receiving one of the devices.

One filter, the Bard Recovery filter, was on the market from April 2003 through October 2005. The manufacturer then modified it to reduce the risk of fracture, selling it as the Bard G2 filter.

During the study, researchers looked at 80 patients who received either device between April 2004 and January 2009.

Of 28 patients who received the older Bard Recovery filter, seven suffered a filter fracture – amounting to a fracture rate of 25 percent. Of the 52 patients who received the Bard G2 filter, six patients had a fracture – amounting to 12 percent.

Researchers noted that the average time of implantation and fracture assessment was about 50 months for patients with the older device compared to about 24 months for patients with the newer Bard filter, meaning the lower fracture rate for the newer device isn’t necessarily as significant as it might seem.

Fragments from the fractured devices drifted to the heart in most cases, but there were also reports of broken pieces migrating to the lung and hepatic vein, which drains blood from the liver.

At least one of the patients had emergency surgery to remove the device fragment, the Wall Street Journal reports.

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