“All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications,” said Dr. William Kuo, an interventional radiologist who runs Stanford Health Care’s IVC Filter Clinic that specializes in removing failed blood clot filters.
“The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
The Bard IVC filter - and those made by other manufacturers - is designed to be used in patients who can’t tolerate blood thinners, and for whom blood clots are a continuing risk. When that risk expands, a filter is often implanted in the inferior vena cava in an effort to prevent a blood clot from reaching the lung and causing an IVC filter pulmonary embolism.
The IVC filter is a spider-like device that sits in the inferior vena cava and corrals a meandering blood clot, holding the clot in its tentacles, or struts, preventing the clot from further migration.
The IVC filter is designed to remain where it was originally implanted. But it often doesn’t, prone instead to IVC filter migration.
Retrievable IVC filters are designed to be removed when the danger has passed. But in the majority of cases, it’s not possible.
IVC filters are designed to preserve life. But in some patients, they have failed to prevent a death and in some cases are alleged to have caused death.
NBC News noted last December that according to records from the US Food and Drug Administration (FDA) and C.R. Bard itself, some 12 deaths and hundreds of IVC filter side effects have been attributed to the Bard G2 filter.
The previous filter the G2 was meant to replace and improve upon - Bard’s Recovery filter - was associated with an equal number of complications and some 27 deaths, according to NBC.
The Bard G2 IVC filter was intended to be an improvement on the Recovery line. However, various claims have suggested that the G2 has not lived up to that expectation. In fact, allegations continue to be made that the G2 carries little, if any, improvement over the original.
Confidential company records obtained by NBC suggest that problems with the Bard G2 filter began to surface within four months of FDA approval for the device. Those records reflect that C.R. Bard was both aware of the problems and concerned about them - yet left the Bard G2 filter and a sibling Bard IVC filter, the G2 Express, on the market without an IVC filter recall for some five years, with an estimated 160,000 sales over the course of that time frame.
An example of the IVC filter issues inherent to the Bard G2 is the IVC filter lawsuit filed by plaintiff Kelly Vlasvich in October 2013 (Vlasvich et al v. C.R. Bard, Inc. et al, Case No. 1:13-cv-07817, US District Court for the Northern District of Illinois).
According to her IVC filter lawsuit, Vlasvich received a Bard G2 filter in February 2009. Less than two years later, in December 2011, Vlasvich was hospitalized with chest pains. Various attempts at a diagnosis and an eventual CT scan revealed metallic fragments in the right ventricle of the heart and in the right lung, which were determined to be “spokes” that had broken off from the defective IVC filter. The device presented as having nine intact struts as compared with the normal 12.
Her IVC lawsuit notes that, “on or about December 22, 2011, to save her life, Kelly Vlasvich underwent open heart surgery for removal of the G2 IVC filter strut from the right ventricle of her heart. It was determined that the two remaining fractured struts in her lungs should not be touched, because removing them would be too dangerous.”
Vlasvich had subsequent surgery for the removal of the Bard G2, which is designed as a retrievable device. However, in the majority of cases IVC filters cannot be successfully retrieved, failing to meet the criteria of the FDA, which holds that retrievable filters should be harvested within a few weeks to a few months after the immediate danger of a blood clot has passed.
Chris Svedise is another Bard patient. As first reported by Heidi Turner in February, Svedise received a Bard G2 Express filter due to a risk for blood clots. This was in 2010. Some years later he asked his doctor to check on the filter. Health care professionals identified IVC filter migration that saw the filter migrate away from its insertion point and drift precariously close to his heart.
Svedise’s surgeon didn’t want to chance removal, due to the complexity. So Svedise turned to Dr. Kuo, who heads a team with advanced skills and techniques to remove failed filters and filter pieces that have broken away.
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“It floated off right in front of our eyes,” Kuo said. “First into the right atrium and then into the right ventricle. He’s very lucky.”
Kuo told NBC News that he has retrieved more Bard filters than those of any other manufacturer.
He maintains the Recovery and G2 filters should have been subjected to an IVC filter recall. “Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled.”