Cordis Inferior vena cava (IVC) filters have been linked to reports of adverse health complications including filter fracture, device migration, and perforation of the heart, lungs, or vena cava.
Free Confidential IVC Filter Lawsuit Evaluation: If you or a loved one has had a Cordis IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
IVC filters are cage-shaped medical devices used to catch blood clots from the lower body before they reach the heart and lungs. Unfortunately, Cordis IVC filter recipients have reported suffering punctured veins, organs, and blood vessels, as well as incidents of the filters migrating to other parts of the body. Two such filters made by the Cordis Corporation (a Johnson & Johnson company) are the OptEase IVC filter and TrapEase permanent filter.
In August 2010, FDA issued a Drug Safety Communication  on removable IVC filters, which included the Cordis OptEase filter. The problem was that the devices were not being removed once the blood clot risk passed, according to the FDA. When IVC filters are left implanted too long, it can lead to a host of problems including:
- Filters can fracture and cause problems in the blood vessels.
- Devices have the potential to migrate from the vena cava into the heart or lungs, where they can become stuck.
- IVC filters have perforated blood vessels.
- Death may result from any or all of these actions.
In addition to these complications, FDA associated the following risks and side effects with vena cava filters in the warning:
- Deep vein thrombosis
- Blood clots clogging the filter
- Fluid around the heart ( hemorrhagic pericardial effusion)
- Air embolisms
- Edema in the lower legs
Cordis IVC Filter Linked to High Fracture Rate, Study Finds
A January 2012 study published in JAMA Internal Medicine  identified a high fracture rate associated with the Cordis TrapEase IVC filter. Researchers looked at 20 patients who received the filters and found that half the devices fractured within 50 months of being implanted. Previous studies have found that the fracture risk increases the longer IVC filters are left in place.
Related Article: IVC Filter Lawsuit Update
Cordis IVC Filter Recall
In August 2013, FDA announced a Class I recall  for approximately 33,000 Cordis OptEase IVC filters over concerns that instructions provided with the devices were unclear, which could lead healthcare providers to implant them backward. Affected models were distributed from May 2010 to April 2013. The recall was accompanied by an “URGENT Medical Device Correction” letter to customers which included “additional information to minimize the likelihood of implanting the filter backward.”
Cordis IVC Filter Complications
- IVC Filter Fracture
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Ventricle Tachycardia
- Lower Limb DVT
- Hematoma or Nerve Injury at the Puncture Site
- Constant and Severe Pain in the Heart, Chest, or Elsewhere in the Body
- Pulmonary Embolism
- And more
PRESERVE Study to Investigate Cordis IVC Filter Safety
The first large-scale, multi-specialty research trial to evaluate the safety of IVC filter use kicked off in 2015 with participation from 7 filter manufacturers, including Cordis. The 5-year study, entitled Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE), will address concerns that retrievable IVC filters can migrate or break apart after being implanted, leading to significant health risks for patients.
“The PRESERVE study will benefit patients by helping determine how well filters prevent pulmonary embolism and when retrievable filters should be removed,” said Peter Lawrence, Vice President of the Society for Vascular Surgery (SVS). Manufacturers and devices that will be included in the study are:
- ALN Implants Chirurgicaux (ALN IVC Filters)
- Argon Medical Devices, Inc.
- Cook Incorporated (Cook Günther Tulip IVC Filter)
- Cordis Corporation (Cordis OptEase Retrievable Vena Cava Filter)
- Volcano Corporation (Crux Vena Cava Filter System)
PRESERVE will investigate the safety of IVC filters, including 2,100 test subjects at about 60 centers across the U.S. There will be at least 300 subjects for each participating filter, and patients will be evaluated every 6 months post-procedure up to 24 months or filter retrieval.
See all related medical device litigations our attorneys covered so far.
Do I Have a Cordis IVC Filter Lawsuit?
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focuses on the representation of plaintiffs in Cordi's vena cava filter lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had a Cordis IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.