In a July 13 letter, the U.S. Food and Drug Administration (FDA) called out IVC filter maker C. R. Bard on medical device reporting violations. Inspection of the Bard Peripheral Vascular facility in Tempe, Arizona, in late 2014 revealed that Bard failed or refused to submit reports regarding the safety of its IVC Denali Filter Delivery System.
Bard is already in hot water for its allegedly defective inferior vena cava (IVC) filters. IVC filters are spider-like devices inserted into the vena cava to prevent blood clots from gathering near vital organs, thereby reducing the risk of stroke and other fatal conditions. But plaintiffs in Bard IVC filter lawsuits claim that Bard’s IVC filters can be just as deadly as the health problems they are supposed to prevent. Multiple studies have shown that Bard retrievable IVC filters can break apart or become wholly dislodged within the body, leading to severe and sometimes fatal problems like vena caval perforation or device migration.
IVC filter lawsuits are backed up by over 900 adverse event reports that were received by the FDA between 2005 and 2010, when the agency issued a safety alert about the risks of long-term IVC filter use. Lately, patients and practitioners have questioned whether retrievable IVC filters confer any benefit at all, potential risks aside.
In its letter to Bard, the FDA took issue with the medical device manufacturer’s handling of evidence of the risks of its Denali IVC filter. Specifically, Bard failed to submit a medical device report within 30 days after it received information “that reasonably suggests that a device that [Bard] markets has malfunctioned and this device or a similar device [Bard] markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.” According to the FDA, Bard filed such information under “device malfunction” when in fact it should also have been filed under “deaths.”
In addition to failing to submit the required reports for its Denali IVC filter, Bard also did not provide justification for “why such malfunctions would not be likely to cause or contribute to a death or serious injury, if the malfunctions were to recur.” In other words, Bard neither filed the reports in question nor filed an explanation for why it did not file the reports.
The FDA also identified several medical device reports filed by Bard with incomplete or missing patient information. Again, Bard also did not submit an explanation for why this data was not provided. The FDA has warned Bard that if it does not promptly correct these and other violations, the agency may take regulatory action without further notice.