510(k) Process Implicated in Vena Cava Filter Deaths

Twenty-seven patients died from complications related to CR Bard's Recovery vena cava filter, which had passed FDA's criteria for substantial equivalence.

Nancy Crotti

FDA has acknowledged that a former CR Bard employee expressed concerns about one of the company's blood-clot filters that the agency ultimately approved, and that has been linked to 27 deaths.

That employee, Kay Fuller, told the agency that the company had not conducted a specific non-clinical test on the Recovery vena cava filter before applying for regulatory clearance in 2002, according to an NBC News investigation. In a November 2015 letter, FDA told Sen. Charles Grassley, R-IA, chair of the Senate Judiciary Committee, that Bard submitted those test results after an FDA request, and that the results satisfied the agency. FDA said it approved sale of Recovery because "the proposed device was substantially equivalent to a predicate device," and it therefore satisfied FDA's key 510(k) benchmark. (Fuller is listed as the contact for K022336 but not on the related documents K031328 and K050558.)

Grassley wrote to FDA last September with several questions about its approval of Recovery following a 38-patient clinical trial, and about Fuller's allegation that her signature on the application was forged. NBC described Fuller as a veteran regulatory specialist. She subsequently left Bard, which called her forgery allegation "flatly untrue."

Bard told Qmed in September that its filters undergo a thorough battery of testing in compliance with federal law, and are evaluated by FDA before reaching the market. "They are implanted by physicians only after careful consideration of the risks and benefits of the device in light of each patient's condition," the company statement said. It did not respond to a request for comment on FDA's response to Grassley.

The company has also launched a website that it says is dedicated to sharing the facts about its VCF filters.

Bard replaced Recovery with a newer model in 2005, but NBC says there are still about 20,000 people with one inside of them. 

FDA declined to say whether it is investigating Fuller's allegations of forgery, but said it takes such allegations "very seriously."  The Senate Judiciary Committee's office and FDA have not responded to requests for further correspondence or comment.

Recovery's clearance appears to have been an instance of "predicate creep," according to Nalini Rajamannan, MD a Sheboygan, WI-based cardiologist and medical device safety activist.

Because of the allegations of a forged signature, FDA should halt U.S. sales of successor devices to Recovery, which Bard stopped manufacturing in 2005, Rajamannan said. That hold should remain until the forgery allegations are investigated and until Bard reviews the clinical test results and adverse events reported to FDA, she added.

FDA should also review the clinical test results with Fuller, the cardiologist said.

Meanwhile, patients have been taking Bard to court,  and FDA commissioner nominee Robert Califf, MD, may face questions about FDA's clearance and approval of medical devices with higher than anticipated adverse event rates.

There has been an uptick in litigation related to vena cava filters, which can potentially migrate within patients, possibly puncturing the vena cava.

FDA points out that since the Recovery's time, it has issued safety communications, one in 2010 and an update in 2014, advising the public of problems observed with vena cava filters, including device migration, filter fracture, embolization, perforation of the vein, and difficulty removing the device. FDA has recommended that physicians consider removing implanted filters in some patients, and has required filter manufacturers to engage in additional post-market surveillance.

Here's the full PDF of FDA's letter:

How the 510(k) Process Was Implicated in Vena Cava Filter Deaths

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

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