Bard Given FDA Warning Letter
The Food and Drug Administration (FDA) has sent a warning letter to C.R. Bard, the manufacturer of inferior vena cava (IVC) filters, including the Denali IVC Filter. because they felt the company had not adequately addressed and corrected violations they found at two of the company's facilities. Bard had previously been made aware of these violations after the FDA cited them during inspections that occurred between Nov. 18, 2014 and Jan. 5, 2015 at their location in Tempe, Arizona and between Oct. 6, 2014 and Nov. 25, 2014 at their Queensbury, New York facility.
Bard Wrongly Labels Serious IVC Filter Injuries As "Device Malfunctions"
The FDA letter raised questions regarding Bard's adherence to Quality System Regulations at the Tempe facility. Among the numerous violations they found, one of the most troubling included the classification of at least a half-dozen serious injuries and deaths as “device malfunctions,” including one case in which a G2 filter broke and the filter arm that became detached caused severe bleeding and necrosis in one of the patient's lungs, a condition that was ultimately fatal.
Other reports were misclassified, included some involving the perforation of the vena cava, pericardial effusion and a number of injuries that ultimately required surgery to correct. At least two reports included descriptions of 10 patients who underwent unsuccessful surgeries to remove an IVC filter, but which failed to explain exactly why that happened.
In addition to being cited for their actions regarding IVC filters, the FDA Warning Letter also cited the company for selling the Bard Recovery Cone Removal System, which is used to retrieve several of the company’s IVC filters, without obtaining FDA approval first. The agency became concerned over the device during the Queensbury inspection when they determined that the item was being sold without Bard asking for premarket approval or even an exemption, which means that FDA researchers have never had an opportunity to test the safety or efficacy of the product.
IVC filters are tiny wire devices that are implanted in a patient’s circulatory system in order to stop blood clots in their tracks before they travel through the bloodstream and end up in the lungs or the heart. Previously, the FDA issued a safety communication in 2010 after they received nearly 1000 reports of significant complications over the previous five years that were tied directly to the use of the filters.
The issues brought up by this warning letter are very concerning, and suggest that Bard is not living up to its duty to follow proper procedures or to follow proper Medical Device Reporting requirements, which are designed to protect consumers, which is very important in the medical device industry.