Revisiting Study Finding Higher Perforation Rates for Cook Celect IVC Filter

September 12, 2017, 6:30PM. By Gordon Gibb

Denver, COWe’re just beyond the second anniversary of the release, and publication of a study in August, 2015 that placed a particular focus on IVC filters manufactured by Cook Medical, and their Cook Celect IVC filter line. It should be noted that inferior vena cava filters made by other manufacturers have been similarly problematic and have suffered failures not unlike those of Cook Celect filters.

However, researchers from Northwestern University and the University of Colorado determined that strut perforations associated with the Cook Celect line were found to be at a higher rate when compared with perforations linked to other manufacturers.

IVC filters are spider-like devices placed in the inferior vena cava, the primary artery that brings deoxygenated blood up from the lower extremities towards the heart and lungs. In older adults, the lower extremities is where most blood clots can form and travel up the inferior vena cava, where a migrating clot can cause a life-threatening pulmonary embolism if it reaches the lung. Blood thinners are normally prescribed to thin the blood as a hedge against blood clot formation. However, in patients who can’t tolerate blood thinners or who are at a heightened risk for blood clot, an IVC filter is often prescribed.

The IVC filter, such as the C.R. Bard G2 IVC filter or those manufactured by Cook Medical in the Cook Celect line, is placed in the inferior vena cava with a catheter, where it is designed to linger and ‘catch’ migrating blood clots, preventing same from travelling up the inferior vena cava. Thin, metal struts hold the IVC filter in place, while additional struts serve to entrap blood clots.

At one time more commonly used as a permanent response to a patient with chronic risk for blood clots, in later years IVC filters have evolved to be retrievable, and are thus employed as a short-term response to a risk for blood clot.

There have been difficulties, however with retrieving the devices. Many have failed, when pieces of the IVC filter have broken free and migrated up through the inferior vena cava to the heart and lungs. In some cases, the entire filter has migrated away from the initial point of insertion.

There have also been instances where the anchoring struts of the IVC filter have perforated the arterial walls – and therein lay the primary finding of the 2015 study with regard to the Cook Celect IVC filter, found by researchers to have a higher rate of perforation when compared with the REX Option filters, made by REX Medical. Researchers were assessing the retrievably of IVC filters, when they happened upon the perforation issue.

To that end, Cook Celect filters were shown in the study to have a strut perforation rate of 43 percent. In comparison the REX Option device was shown to have a perforation rate of less than
one percent.

Cook Celect IVC filter lawsuits are consolidated in MDL No. 2570 IN RE: Cook Medical, Inc. IVC Filters Marketing, Sales Practices and Products Liability Litigation in the Southern District of Louisiana.