IVC Filter Complications – Filter Occlusion
In addition to the problem of filter migration, embolization of the struts and penetration of the IVC, there is an additional complication: the blockage or occlusion of the filter due to blood clots being captured by the filter or forming as a result of filter placement. According to a February 2013 study in Vascular Medicine, placement of an IVC filter may promote the formation of blood clots. “Occlusion of IVC filters remains their most frequent complication,” the authors wrote.
IVC Filter Complications – The MAUDE Database
One of the best sources of information about IVC filter complications is within a database maintained by the U.S. Food and Drug Administration known as the Manufacturer and User Facility Device Experience (MAUDE) database. Researchers use this database to study problems associated with the filters.
Federal law requires manufacturers and importers of medical devices, as well as medical facilities (such as hospitals, ambulatory surgical centers, nursing homes and outpatient clinics), to let U.S. Food and Drug Administration (FDA) know when they have learned of significant problems associated with a medical device.
They must file reports and those reports, along with the information contained in them, are then stored in the MAUDE database. Sometimes voluntary reports are also filed by health care professionals and consumers.
Perhaps the most important element to realize about the reports in the MAUDE database is that each report involves either death, serious injury or malfunctions that “would be likely to cause or contribute to a death or serious injury” if these defects were to occur again.
“He allegedly experienced worsening pain and discomfort as fragments of the filter ‘became embedded in the tissue throughout his body.’ Decedent allegedly took his own life…after being ‘unable to find relief from constant pain.’”
-From a MAUDE database report submitted to the FDA on October 22, 1015.