C.R. Bard, maker of a defective 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 troublesome filters. FDA also warned Bard over its inadequate responses to the problem. The agency further cited Bard for failing to properly report deaths and other serious adverse events related to its IVC blood clot filters. The warning letter reveals that the IVC blood clot filter maker concealed bad outcomes.
The warning letter also addressed violations found at Bard plants in Tempe, AZ and Queensbury NY.
Bard violated FDA Law
The FDA stated that Bard violates law by making and selling the Recovery Cone Removal System, Model RC-15, without marketing clearance or approval. The RC-15 is “adulterated,” wrote FDA, because Bard does not have premarket approval (PMA) to sell it. Bard also failed to notify FDA of its intent to introduce the device into commercial distribution, as required by law.
The FDA also warned Bard about another Recovery Cone Removal System, Model FBRC, which Bard also failed to usher through proper FDA marketing clearance or approval. The FDA warned Bard in this instance because Bard was marketing the Recovery Cone Removal System for specialized intended use, namely percutaneous removal of inferior vena cava filters, specifically Bard’s G2X Filter, G2 Express Filter, and G2 Filter.
Percutaneous refers to any medical or surgical procedure in which access to organs or other tissue is accomplished by needle-puncturing the skin, as opposed to an “open” approach where inner organs or tissue are (typically) exposed with a scalpel.
The FDA also faulted Bard for its procedures governing complaint investigation activities. 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.”
Blood Clot Filter Maker concealed Bad Outcomes
The agency also said that Bard failed to file a death related to the blood clot filter and instead filed it as a malfunction Medical Device Report (MDR). Bard also filed as malfunctions (think: euphemisms) what were in fact much more serious, negative outcomes, for example: an Eclipse Filter detached, resulting in pericardial effusion and cardiac catheterization; a G2 Express Filter broke and required surgical intervention; a Denali Jugular System detached a filter arm and embedded in an IVC wall with filter retrieval; a G2 Filter detached filter limb lodged in a renal vein with IVC wall perforation and blood thinner treatment; a G2 Express Filter IVC perforation resulted in an aneurysm; a G2 Filter resulted in abdominal pain with filter legs protruding through the IVC wall and requiring percutaneous removal; complaints came from at least 10 patients who were exposed to scheduled retrieval surgical procedures to remove an IVC filter that were not successful; and the list goes on.
Bard responses Inadequate
Bard made several responses to FDA in regard to these issues and the FDA wrote to Bard regarding its complaint handling system: “Your response is inadequate and does not assure that your complaint handling system reviews and evaluates complaints adequately.”