Argon Option Elite IVC Filter Lawsuit Alleges Device Fractured, Leaving Metal Fragment Inside Woman

Lawsuit claims IVC filter tilted and became embedded in woman’s vena cava, requiring multiple removal procedures.

A Florida woman has filed a product liability lawsuit alleging a defective Argon Option Elite IVC filter caused serious complications, including blood vessel damage and blood clots.

The complaint (PDF) was brought by Laura Works in the U.S. District Court for the Middle District of Florida, naming Rex Medical LP, Argon Medical Devices Inc. and Rex Medical Inc. as defendants.

Works claims the manufacturers knew or should have known the device was prone to fracture, migration and perforation, but continued selling it without adequate safety testing, corrective measures or warnings to the medical community.

IVC Filter Problems

IVC filters are small, spider-shaped medical devices placed inside the inferior vena cava to capture blood clots before they reach the lungs and cause a potentially life-threatening pulmonary embolism. They are commonly implanted in patients who cannot safely use blood-thinning medications or whose conditions cannot be adequately managed with those drugs.

However, safety concerns have emerged over certain IVC filter designs following reports that the devices may tilt, shift out of position, break apart or puncture blood vessel walls after implantation. In some cases, metal struts may penetrate the vena cava and surrounding organs, while broken fragments can move through the bloodstream and become lodged in other parts of the body.

These risks have been central to product liability lawsuits involving numerous IVC filter devices, including Cook Medical’s Celect and Gunther Tulip filters, along with several models manufactured by C.R. Bard. Individuals allege the companies failed to adequately evaluate the devices’ safety or warn patients and physicians about potentially serious complications.

Tens of thousands of patients have filed Cook IVC filter lawsuits and Bard IVC filter lawsuits in state and federal courts nationwide, claiming defective designs, inadequate safety testing and insufficient warnings exposed them to preventable injuries.

Argon Option Elite IVC Filter Fracture Allegations

According to the complaint, Works received an Argon Option Elite IVC filter on September 29, 2023, at Tampa General Brooksville in Brooksville, Florida. The device was implanted by Dr. Adithya Mathews.

On November 8, 2024, Works underwent a procedure to remove the filter because it was no longer needed. However, Mathews was unable to retrieve the device since it had allegedly tilted, causing its retrieval hook to become embedded in the vena cava wall. The complaint maintains that this contradicted claims that the filter could be easily removed.

Works underwent a second removal procedure on January 17, 2025, performed by Dr. Cliff Davis, who used endobronchial forceps to extract the embedded filter. At the time, medical imaging revealed that the device’s metal struts had perforated the vena cava wall.

Although Davis removed the main portion of the filter, a fractured metal strut remained inside Works. Davis also discovered a laceration in the vena cava, which required repair with stent grafts. The broken strut could not be removed and allegedly remains inside Works’ body.

On January 22, 2025, CT imaging revealed significant inflammation near the former filter location, where the broken strut and stent grafts remained. Works required another surgical procedure on February 6, 2025, after developing acute thrombosis, or blood clot formation, in the affected area.

The lawsuit attributes the complication to trauma from the filter removal, the retained metal fragment and the stent grafts. Works subsequently required an extended course of anticoagulation treatment.

Works alleges the Option Elite filter lacks sufficient structural stability and fatigue resistance to withstand normal forces inside the body, increasing the risk of fracture, migration, tilting, embedment, perforation and thrombosis. She also maintains the device can promote blood clot formation, despite being intended to prevent potentially fatal complications from blood clots.

“At all times relevant hereto, Argon and the Rex Defendants knew the Option Elite Filter was defective and knew that the defect was attributable to the design’s failure to withstand the normal anatomical and physiological loading cycles exerted in vivo.”

— Laura Works v. Rex Medical LP et al.

The complaint raises allegations of negligence, inadequate warning or instruction and design defect. It seeks punitive and general damages for past and future physical pain, suffering and mental anguish.

IVC Filter Lawsuits

The Argon Option Elite IVC filter lawsuit joins a broader history of product liability litigation involving these kinds of medical devices.

Thousands of similar claims against C.R. Bard have already been consolidated in the District of Arizona before U.S. District Judge David G. Campbell for coordinated discovery and pretrial proceedings. Those cases involve claims that IVC filters fractured or caused other serious complications.

Following several bellwether trials, including substantial jury verdicts against Bard, most of the claims were resolved through settlements. In 2019, Campbell began returning unresolved Bard IVC filter lawsuits to the federal courts where they were originally filed for further proceedings.

Separate litigation involving Cook Medical’s Celect and Gunther Tulip IVC filters has also been centralized in the Southern District of Indiana before U.S. District Judge Richard L. Young, where attorneys have been preparing representative cases for potential bellwether trials while pursuing settlement negotiations.

Sign up for more legal news that could affect you or your family.