In August, 2011, the Food and Drug Administration received a personal injury report of a patient requiring hospitalization due to the breakage of an implanted Bard inferior vena cava (IVC) Filter. Specifically, it was a G2 IVC Filter. According to the report, the fracture of the IVC arm was found on a CT scan. This incident, which is not isolated, came after an FDA-issued warning in August 2010, citing problems with retrievable IVC filters including hematomas. In a study published in 2010 in the Annals of Vascular Surgery, migration/tilt was higher in Bard filters compared to other filters.
IVC filters are small, spider-like devices which are surgically inserted into the inferior vena cava to prevent blood clots from reaching the lungs. But these devices can suffer from fatigue, causing them to fail and fracture, ultimately migrating through the body causing damage which could be life-threatening. The reported problems with the Bard IVC filters include a high rate of perforation of the vena cava resulting in perforation of the surrounding tissue, intestines, spine, vertebrae and arteries.
Complications due to a failure of an IVC filter can include pulmonary embolus, severe and constant pain in the chest, heart or other parts of the body, respiratory distress, tissue perforation, organ perforation, vessel perforation, and hemorrhage. This is, quite obviously, a most serious matter.
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