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Serious complications such as filter fracture, migration, and perforation of vital organs, arising out of the implantation of a defective Inferior Vena Cava (IVC) Filter, including the Bard Peripheral Vascular RecoveryTM and G2TM IVC filters, have been associated with life-threatening injuries and death.
An IVC filter is a medical device made of very thin wires that is surgically implanted in a patient's vena cava vein (the large vein that carries de-oxygenated blood from the lower half of the body into the heart) to trap blood clots (emboli) before they can reach the arteries in the lungs (pulmonary arteries). Blood clots in the lungs (pulmonary emboli) are dangerous and often result in death because they can block the pulmonary arteries and interfere with the lungs' ability to oxygenate the blood.
Many companies manufacture and sell IVC filter devices. However, the Bard Peripheral Vascular Recovery™ and G2™ IVC filter models have been associated with a particularly high rate of fracture and migration which may be attributed to the filters' design. The Recovery™ filter, which was commercially available from April 2003 to October 2005, was voluntarily removed from the market by the manufacturer in 2005 and replaced by the G2™ model which was modified to reduce filter fracture and migration.
IVC filters have the potential to fracture. The "struts" or "legs" of the filters can break off and migrate (travel) from the vena cava to other parts of the body, including vital organs such as the heart or lungs. Complications associated with device fracture and migration may include:
Warning signs of device failure include sudden onset of chest or other bodily pain following implantation.
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