Patient Says Bard Heart Implant Splintered

CHICAGO (CN) - A heart implant splintered, requiring immediate open-heart surgery and leaving fractured metal in a woman's lungs that cannot be safely removed, she claims in court.

Kelly Vlasvich sued C.R. Bard and Bard Peripheral Vascular in Federal Court.

Vlasvich underwent surgery in 2009 to insert a Bard G2 inferior vena cava (IVC) filter into her heart to reduce the risk of pulmonary embolism.

Two and a half years later, she "was admitted to the hospital for moderate chest pain and discomfort that had gradually worsened over several days. Her symptoms included nausea, vomiting, sweating, difficulty breathing, cough, weakness and dizziness," according to the complaint.

She was diagnosed with pericarditis, inflammation of the heart, and underwent a pericardiocentesis to evacuate fluid from the sac around the heart.

She suffered continuing pain and "underwent a CT scan which showed 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," according to the lawsuit. "On or about this date, Kelly Vlasvich discovered that the defendant's IVC filter was defective. Upon review of images of the abdomen, the IVC filter only had nine struts when it originally had twelve.

"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 claims she still suffers pain and is permanently disfigured from the defective IVC filter.

She seeks punitive damages for negligence, breach of implied warranty, negligent misrepresentation, strict product liability and loss of consortium.

She is represented by Jim Navarre with Mossing & Navarre.

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