The manufacturer of the Bard inferior vena cava (IVC) filter and its retrieval system has been issued an FDA warning letter for failing to notify the federal agency of life-threatening device malfunctions. The FDA specifically notes that Bard misfiled consumer complaints (including a reported patient death) and developed the IVC retrieval device, known as the Recovery Cone Removal System, without FDA approval.

The U.S. Food and Drug Administration’s warning letter to Bard states: “Percutaneous retrieval systems, such as the Recovery Cone Removal System, Model RC-15, are regulated as manual surgical instruments intended for specialized use within a specific medical specialty, and thus require marketing authorization in order to be legally marketed in the United States.”

In addition to manufacturing the IVC filter retrieval product without FDA clearance, the agency states that complaints of unsuccessful IVC removal procedures lacked important information, such as what occurred after the failed attempt at IVC removal. For example, did it require repeated surgery or were there other potential complications?

The FDA warning letter also specifically mentioned violations in Bard facilities located in Queensbury, N.Y. and Tempe, Ariz. In the Queensbury facility, the FDA noted that the cleaning processes for IVC filters were not validated. In Tempe, the facility violated Medical Device Reporting requirements by not informing the agency within 30 days of receiving device malfunction reports.

This is not the first time the FDA has informed Bard of violations after inspection observations, and the agency has not been pleased by the company’s lack of action to correct the issues. The FDA warning letter is considered a serious next step. 

IVC Filters Explained

The inferior vena cava (IVC) filter is a cage-like device that is placed into the large leg veins as a way to trap blood clots before they can travel to the heart or lungs. The blood clots are kept trapped in the IVC filter until the body can dissolve them. This method for preventing blood clots is an effective alternative for patients who cannot use an anticoagulant.

Blood clots can pose a life threatening risk to patients if left untreated, as they can cause serious health conditions such as heart attacks or pulmonary embolism.

The U.S. Food and Drug Administration approves IVC filter implantation for the following cases:

• When anticoagulant therapy has failed to work in thromboembolic diseases
• Emergency treatment following massive pulmonary embolism when expected benefits of traditional therapy are reduced
• Treating pulmonary thromboembolism when blood thinners shouldn’t be used
• Recurring pulmonary embolism when anticoagulant use has failed

The FDA has recently warned against the long-term use of an IVC filter after receiving hundreds of adverse event reports. The federal agency now recommends that doctors remove the filters between 29 and 54 days after implantation in order to reduce the risk of IVC complications.

IVC Filter Complications

The FDA has received more than 900 IVC filter adverse event reports so far. Of those, the majority reported that the medical device migrated to another area of the body. Others reported detached device components, IVC perforation, and filter fractures.

The FDA believes that patients will reduce the risk of IVC filter complications by removing the device as soon as the risk of forming blood clots has diminished.