In 2010, the FDA reported 921 incidents of adverse effects suffered by patients who had an IVC filter implanted to reduce the chances of blood clots traveling to their lungs, a condition known as a pulmonary embolism (PE). Of those events, 328 were linked to migration of the device to another area of the body. As a result, the FDA recommended that doctors consider taking the filter out as quickly as possible after the threat of a PE subsides. In May 2014, the agency updated that warning to recommend doctors remove IVC filters between 29 and 54 days after implantation, or as soon as possible after protection from a PE is no longer needed.
The FDA then sent a warning letter to IVC manufacturer C.R. Bard in July 2015, stating that the company’s IVC filter retrieval system had been neither cleared nor approved by the agency. The letter also alleged that Bard had committed several violations regarding the marketing and manufacturing of its filters. These violations included:
- Failing to report malfunctions of its IVC filters, and that those malfunctions had resulted in severe injuries and deaths.
- Failing to properly establish procedures to evaluate complaints related to its Eclipse, G2 and G2X IVC filter models.
- Failing to follow proper manufacturing practices in the manufacture, packaging and storage of IVC filters. Specifically, the FDA pointed out that Bard’s IVC filter cleaning processes in its Queensbury, N.Y. facility had not been validated.