September 9, 2015: Comparative Study Reflects Significantly Higher Perforation Rate For “Celect” Cook IVC Filters

IVC Filter Lawsuit News – Results from a study comparing IVC filter retrieval rates indicate that the Cook Celect IVC filter has a significantly higher incidence of major blood vessel perforation (43%) versus the study comparator, Rex Medical’s Option IVC filter (0%). These findings are of importance to the medical community and patients, as the U.S. Food and Drug Administration (FDA) had previously reported that in some instances, the “cage-like” prongs of an IVC filter may puncture the wall of the vein in which it was placed, or migrate to puncture blood vessels and organs.

An inferior vena cava (IVC) filter is a small, cage-like medical device that is inserted into a patient’s inferior vena cava (the main vessel returning blood from the lower half of the body to the heart) to capture blood clots and prevent them from reaching the lungs where they can result in a life-threatening pulmonary embolism (PE). IVC filters are used in patients who are a risk for developing pulmonary embolism (blood clots in the lungs) when anticoagulants (blood thinners) are not indicated. Although IVC filters are designed to be permanent, some these devices may be removed.

The study, A Comparison of Retrievability: Celect versus Option (Journal of Vascular and Interventional Radiology, June 2015), compared the medical histories of 99 “Celect” IVC filter recipients and 86 “Option” IVC filter recipients whose IVC filters were retrieved about 2 months after the device was implanted. The researchers concluded that retrieval rates for the Celect and Option filters were not significantly different, although retrieval of the Option filter required a significantly increased amount of fluoroscopy time, and a significantly greater usage of adjunctive retrieval techniques compared to the Celect IVC filter. The Celect IVC filter had a significantly higher rate (43%) of strut perforation when compared to the Option IVC filter (0%).

Cook Faces IVC Filter Lawsuits

Bloomington-based Cook Group, Inc., faces over 100 IVC Filter Lawsuits in a multidistrict litigation (MDL 2570) in the Southern District of Indiana. Cook Celect and Cook Gunther Tulip filters have been identified in the product liability lawsuits.

FDA IVC Filter Safety Announcements

On August 9, 2010, the FDA announced that since 2005 it had received 921 medical device adverse event reports involving IVC filters of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. The agency also stated that long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation. It was also recommended that while the FDA is conducting its investigation, physicians caring for patients with retrievable IVC filters should consider removing the filter as soon as protection from PE is no longer needed.

In a second safety announcement on May 6, 2014, the FDA reported IVC filter adverse events and product problems have included:

  • device migration
    filter fracture
  • embolization (movement of the entire filter or fracture fragments to the heart or lungs)
  • perforation of the IVC
  • difficulty removing the device

Some of these events according to the agency, led to adverse clinical outcomes.  Lower limb deep vein thrombosis and IVC occlusion were identified as other possible long-term patient risks.

The FDA recommended that doctors responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.

Obtain A Free IVC Filter Lawsuit Evaluation

The Weinberg Law Firm is currently assisting individuals experiencing IVC filter complications. If you or a loved one has been injured and you would like information regarding an IVC Filter Lawsuit, please contact our personal injury lawyers at 1-877-934-6274. You can also contact our firm by submitting the easy-to-use “Free Legal Case Evaluation Form” found on this page.

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