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Retrievable inferior vena cava (IVC) filters are porous barriers. They are implanted inside the main vessel, the inferior vena cava (IVC), through which blood from the lower extremities and pelvis is carried back to the heart. 1 This is normally done on an outpatient basis.
IVC filters are typically implanted in patients who are at risk of blood clots in the lungs, known as pulmonary emboli (PE), when anticoagulant medications cannot be used or have not been effective. 1 2
Function of Inferior Vena Cava Filters
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The purpose of IVC filters is to prevent blood clots that have formed in the lower extremities or pelvis from entering the lungs or heart. If blood clots do enter the heart or lungs, they could cause potentially serious or fatal harm.
Retrievable IVC filters are approved by the U.S. Food and Drug Administration (FDA) to be implanted either temporarily or permanently. 1
Doctors may consider implanting a retrievable IVC filter when a patient has recurrent pulmonary embolism. Use of the devices for preventing recurrent PE is approved by the FDA in these situations: 2
- Anticoagulant therapy has failed.
- Anticoagulant therapy is contraindicated.
- Emergency intervention is required after a massive pulmonary embolism when anticipated benefit of conventional therapies is reduced.
Preventing Pulmonary Embolisms
The respiratory system, working with the circulatory system, allows oxygenated blood to circulate throughout the entire body. For most people, these systems function without impairment.
Some retrievable IVC filters have demonstrated patterns of failure, with some studies reporting many problems.
For some, however, there may be certain diseases present or a tendency that causes the body to form tiny clots of blood that can inhibit blood moving through the body efficiently. The clots are called thrombi.
These clots often originate in the deep veins of the legs. The causes vary, but when these thrombi form in the legs it is an event referred to as deep vein thrombosis, or DVT.
These DVT clots can migrate into the main portion of the inferior vena cava, which can transport them to the upper body and into lungs or heart. If the clots enter the lungs and block the passage of blood in the vessels in this organ they are known as pulmonary emboli — PE for short. PE carry the potential for serious injury or death because of the vital function the lungs play in providing the body with oxygenated blood.
A retrievable IVC filter works much like the screen inside the end of a kitchen faucet. The screen prevents mineral deposits contained in the water supply from passing through the faucet.
Retrievable IVC filters are intended to intercept migrating DVT before they reach the lungs. The blood that passes beyond the point of the retrievable IVC filter is “strained” of clots, but the retrievable IVC filter can be removed once the risk of PE has passed.
Reported Adverse Events
Adverse events reported to the FDA regarding retrievable IVC filters include:2
Filter migration & fracture
Embolization of the filter or filter fragments to other organs
IVC Filter Risks
Retrievable IVC filters are subjected to normal anatomic pressures that exist inside the inferior vena cava as blood is pumped through it by the beating heart.
Some retrievable IVC filters have demonstrated patterns of failure, with some studies reporting many problems. 3 4
Some of these risks carry the potential for serious injury or death.
IVC Filter Removal and FDA Actions
The FDA has not at this time ordered a recall of retrievable IVC filters. However, the FDA has issued a recommendation to doctors advising them to remove retrievable inferior vena cava filters as soon as the protection from pulmonary embolism is no longer needed. Doing so may reduce the risk of complications with IVC filters, the FDA said. 5
Meanwhile, the FDA is keeping watch on the manufacturers of retrievable IVC filters. In July 2015, IVC filter manufacturer C.R. Bard, Inc., of Murray Hill, New Jersey received a warning letter from the FDA for adulterating and misbranding violations for some of its devices. This included the Recovery Cone Removal System Model RC-15, “intended to percutaneously remove the Recovery Filter, Recovery G2 Filter and the G2X Filter as indicated.” 6
In one case, Bard filed the death of a patient implanted with a “detached filter arm” of a G2 IVC filter that had embolized “with associated areas of hemorrhage and necrosis in the right lung” as a product malfunction.
An inspection of Bard’s Tempe, Arizona, manufacturing facility found quality system violations pertaining to the receipt, review, and evaluation of product-related complaints. 5
In one case, Bard filed the death of a patient implanted with a “detached filter arm” of a G2 IVC filter that had embolized “with associated areas of hemorrhage and necrosis in the right lung” as a product malfunction. The FDA noted it should have been listed as a death. Several other serious injuries regarding IVC filters were filed as malfunctions, as well. 6
The FDA also faulted Bard for additional quality system regulation violations. Specifically, the FDA was troubled by the way Bard had not validated its manufacturing process for several IVC filters to ensure they met with required specifications, especially regarding removal of chemical processing contaminants. 6
Cordis IVC Filter Recall
In March of 2013, Cordis Coorporation recalled 33,000 IVC units because of a risk of filters being implanted backwards. The recall applied to Optease Retrievable Vena Cava Filters distributed between May 6, 2010 and April 2, 2013.
Bard, Cook Medical and other manufacturers continue to distribute IVC filters and have not issued any blood clot filter recalls at this point.
- U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. May 6, 2014. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm (Accessed October 1, 2015).
- Morales JP, et al., Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism. http://dx.doi.org/10.1016/j.jvsv.2013.04.005. (Accessed October 1, 2015).
- U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. May 6, 2014.; http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm (Accessed October 1, 2015.)
- Durack JC et al., Perforation of the IVC: rule rather than exception after longer indwelling times for the Günther Tulip and Celect retrievable filters. doi 10.1007/s00270-011-0151-9. http://www.ncbi.nlm.nih.gov/pubmed/21448771. (Accessed October 1, 2015).
- Tam MD et al., Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications. doi: 10.1016/j.jvir.2011.10.017. http://www.researchgate.net/publication/51905475_Fracture_and_Distant_Migration_of_the_Bard_Recovery_Filter_A_Retrospective_Review_of_363_Implantations_for_Potentially_Life-Threatening_Complications(Accessed October 1, 2015).
- U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. May 6, 2014. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm (Accessed October 1, 2015.