C.R. Bard, maker of a controversial blood clot filter, received a warning letter from the FDA in July 2015 over Bard’s unapproved use of a device designed to retrieve the company’s filters. In this letter, the FDA cited Bard for failing to report deaths and other serious adverse events in patients using its IVC blood clot filters.
Bard Disregarded the FDA
The FDA stated that Bard sold its Recovery Cone Removal System, Model RC-15, without marketing clearance or approval from the FDA. Bard also failed to notify FDA of its intent to introduce the device into commercial distribution. Not only did Bard fail to obtain premarket approval for the RC-15, but Bard also failed to usher through proper FDA marketing clearance or approval it’s Model FBRC.
Bard continued to ignore FDA requirements as the agency faulted Bard for omitting proper procedures regarding complaint investigation. The agency wrote that Bard did not include adequate instructions for ensuring that “complaints involving a device or device component provided by a supplier are adequately evaluated for root cause of the alleged device failure and that appropriate corrective action is implemented with your suppliers.”
Bard Mischaracterized Bad Patient Outcomes as Device Malfunctions
The agency also said that Bard mischaracterized a death associated with the use of its IVC filter as a device malfunction as opposed to a patient death caused by the filter use. This mischaracterization wasn’t limited to a patient death. Instead, Bard classified a number of serious adverse events as device malfunctions. For example, broken IVC filter arms that needed to be surgically removed or perforations that caused an aneurysm were misclassified as device malfunctions.
Failing to properly report these poor patient outcomes provides misleading results. Without the correct data, the FDA and the public cannot adequately assess the safety of Bard’s IVC filter retrieval device.
IVC Filter Injuries
Although Bard has responded to the FDA’s found shortcomings, the FDA responded by noting Bard’s response was inadequate. The difficulties with Bard's retrieval device seem to highlight the company’s difficulties in this arena. Bard's IVC filters have been found to cause life-threatening complications. If you or a loved one have suffered organ puncture, such as heart or lung puncture, or vein ruptures as a result of a faulty IVC filter, contact Chelsie King Garza for a free consultation today.