A lawsuit has been filed against C.R. Bard over a fractured IVC filter on behalf of an Alabama woman who died after having been implanted with the filter.
Effie R. has filed a lawsuit on behalf of Velvet R., who died after receiving a Denali inferior vena cava (IVC) filter, the Daily Hornet reports. Velvet received the IVC filter on Dec. 7, 2015, at a hospital within her state. The device was implanted to prevent blood clots from reaching her heart or lungs.
The Denali is a fairly new model made by Bard, but is still known to have the same complications as the G2 and Recovery filters – the risk of tilt, migration, fracture or perforation.
The lawsuit alleges that Velvet’s Denali IVC filter failed, creating major medical problems from which she couldn’t recover, and she later died as a result of her injuries.
The Denali also is named in a case report filed in January 2015 in which a a 45-year-old woman nearly died after receiving the Denali filter, also to prevent blood clots from traveling to her heart or lungs. When she returned to the hospital less than six months after implantation, the doctors found that the filter had fractured, and fragments were found in her heart, impaling her heart muscle. She experienced cardiac tamponade, an irregular heart rhythm that can be deadly.
The woman underwent emergency open-heart surgery to pick the fragments out of her body. Afterward, the doctors used an electron microscope to study the pieces, concluding that the filter failed to hold up against normal use due to its weak and inferior design.
The doctors reported, “Electron microscopic fragment analysis revealed high-cycle metal fatigue indicating the filter design failed to withstand this patient’s natural inferior vena cava biomechanical motions.”