IVC Filter Warning Letter: Bard Failed to Properly Investigate Complaints
The IVC filter warning letter charges Bard with violating CFR section 820.198(a), which requires manufacturers to establish reliable procedures for receiving, reviewing and evaluating complaints. The Arizona and New York facilities were both found in violation of this regulation.
As evidence for this failure, the FDA IVC filter warning letter cites several MDRs that were incorrectly filed with the agency. A brief explanation of the MRD reporting system may help to explain this violation.
Medical device reporting regulations (Part 803) require device manufacturers to report to the FDA whenever they learn that one of their devices may have caused or contributed to a death or serious injury. Serious injury is defined as an injury that is life-threatening, permanently impairs a body function or damages a body structure, or necessitates medical or surgical intervention to prevent permanent impairment or damage. Manufacturers are also required to report device malfunctions that would be “likely to cause or contribute to a death or serious injury” if they reoccurred.
As noted earlier, these reports are called Medical Device Reports. They are kept in a searchable database, known as the MAUDE (Manufacturer and User Facility Device Experience) Database. In their MDRs, manufacturers identify each adverse event according to its “event type,” a death, an injury or a malfunction.
Visit our IVC Filter Complications page for a full discussion of IVC filter complications and the database.
The FDA IVC filter warning letter accuses Bard of misreporting the event type in their MDR reports. Specifically, they accuse Bard of filing one report as a malfunction, when it should have been filed as a death. The FDA also accuses Bard of filing several reports that should have been identified as serious injuries, as malfunctions.
For example, in one case, one of the arms of a G2 Bard IVC filter (the arms hold the filter in place in the inferior vena cava) detached and travelled to the patient’s right lung. (The movement of an object or other mass through a blood vessel is referred to as an embolization. Embolization of IVC filter parts via the inferior vena cava to the heart or lungs is a major problem with IVC filters, including several Bard IVC filter models.) In this case, the embolization produced areas of hemorrhage and necrosis (the death of organ cells) in the lung. Though the patient died, the complaint was filed as a malfunction Medical Device Report (MDR).
“Complaint (b)(4) [(b) (4) indicates confidential information has been redacted] for a G2 Filter, embolization of a detached filter arm with associated areas of hemorrhage and necrosis in the right lung was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death.”
July 13, 2015 IVC Filter Warning Letter from U.S. Food and Drug Administration to C. R. Bard, Inc.
In another case, a filter limb detached from an Eclipse filter. According to the letter, this resulted in pericardial effusion and the need for cardiac catheterization. The pericardium is a fluid-filled “sack” that surrounds the heart. In medicine, the word effusion refers to the escape of fluid into a space in the body. Pericardial effusion is a condition in which there is too much fluid in the pericardium. In severe cases, this can prevent the heart from functioning properly and become life-threatening—a condition known as cardiac tamponade.
The IVC filter warning letter does not give specifics of this case, but there have been numerous reports of pericardial effusion and cardiac tamponade resulting from fractured filter parts traveling to the heart and puncturing the heart wall. That may well be what happened in this case. A 2010 study of 189 patients published in JAMA Internal Medicine found that the fracture and embolization of filter fragments was high in two Bard IVC filter models, the Recovery and the G2. The hospital where the study was conducted halted further implantation of the two devices.