August 9, 2010—The FDA warned that IVC filters could fracture and migrate to other parts of the body. The FDA announced that it had received 921 adverse event reports since 2005 involving IVC filters, including devices manufactured by C.R. Bard. Problems included device migration, detachment of device parts, filter fracture and perforation of the inferior vena cava.
The FDA warning coincided with a report released in the Archives of Internal Medicine linking IVC filters manufactured by C.R. Bard with these defects. The study evaluated eighty patients who received two different types of C.R. Bard IVC filters at York Hospital. Twenty-eight patients received an older model that was available from April 2003 through October 2005. Among that group, seven experienced a filter fracture, reflecting a 25% fracture rate. Of the 52 patients who received the Bard G2 model, six patients experienced a fracture, representing a 12% rate of fracture.
At first blush the fracture rates in the Bard G2 IVC filter, seem to demonstrate an improvement over the older model, however the average time of implantation and fracture was about 50 months for patients with the older device compared to about 24 months for patients with the Bard G2 filter. |
