A woman has filed a claim against manufacturers Cook Incorporated, Cook Medical LLC, and William Cook Europe APS, for the alleged misalignment and defective insertion of an inferior vena cava filter, or otherwise known as Cook Medical’s Gunther Tulip System.

The Cook IVC filter lawsuit was filed by plaintiff Umeki S., a woman from Georgia, who received the Gunther Tulip system, or inferior vena cava filter, in May 2006.

After being implanted with the allegedly defective device, she contends, a CAT scan done in July 2015 on the plaintiff’s abdomen and pelvis indicated and revealed that, “her filter has tilted sagittaly approximately 15 degrees, and that her filter struts have perforated her vena cava and are abutting her pancreas and duodenum.”

Additionally, the Cook IVC filter lawsuit argues that because the filter had been implanted for roughly 11 years, it could no longer be removed due to “endothelialization and penetration of the filter struts.”

The alleged contention made in the lawsuit states that the manufacturers knew of the defect but failed to disclose the life-threatening risks and adverse effects of the medical device to the plaintiff, or rather to any medical practitioner or patient.

Specifically, they allegedly failed to disclose that an implantation of the Cook Filter could cause an increased right of post-implantation thrombosis, not disregarding acute DVT, and moreover, that the removal of the device must occur within a very short amount of time. If the device is not removed within the short time span after its implantation, not doing so could cause the device to become irretrievable.

Umeki S. is currently at risk for future “Cook Gunther Tulip Filter Fractures, migrations, perforations and tilting, as well as future recurrent DVT and/or pulmonary embolism,” the Cook IVC filter lawsuit states.

She is currently facing a multitude of health risks, including death, and states that there will be life-long medical monitoring of her condition.

An IVC filter, like the Cook filter, was designed to filter blood clots, known as thrombi, that would instead trek from the body’s lower extremities to the heart and lungs. The filter is designed to be implanted into the inferior vena cava, a vein known to transport or return blood to the heart from the body’s lower extremities.

The thrombi, or blood clots, can travel through the inferior vena cava and into the lungs. And when developed in deep leg veins, they are then called DVT, or “deep vein thrombosis.” If they reach the lungs, they are called pulmonary emboli, or PE.

The IVC filter is designed to filter and prevent blood clots from traveling into the lungs or heart.

Since having been approved by the FDA (Food and Drug Administration) in October 2000, however, several reports of adverse events have been submitted back to them. The number of reports has increased since 2005.

As alleged in this case, serious IVC filter adverse effects and complications have been deemed to occur; these have included filter migration, internal bleeding, perforation of organs, bacterial infection, and death.

The Cook IVC Filter Lawsuit is Case No. 1:17-cv-01398, in the U.S. District Court for the Northern District of Georgia, Atlanta Division.