South Carolina resident Ronald D. was given an Option Elite retrievable inferior vena cava (IVC) filter on April 19, 2015. Ronald was a patient at the University Hospital in Augusta, Georgia, at the time.
A year later, on April 12, 2016, the same doctor who implanted the IVC filter attempted to remove it, until he discovered the filter was tilted at a 45 degree angle. The retrieval hook was embedded in the wall of the vein. Unfortunately, the doctor was unable to retrieve the filter.
Ten weeks later, Ronald went to another doctor to request removal. After an extremely risky surgery, the filter was removed, leaving behind a serious complication.
Shortly after, Ronald filed a lawsuit against the makers of the filter for the life-threatening failure of the device.
“The doctor was eventually able to successfully remove the filter,” the lawsuit says. “After removal of the IVC filter, it was discovered that the IVC wall was damaged where the filter hook had been embedded.”
When the wall of the vena cava is damaged, the patient can suffer significant internal bleeding and/or death. Many doctors refuse to attempt removal of failed IVC filters because of the high risk. The filter could fracture during removal, or removal of a tilted filter or one that has perforated the vein could cause life-threatening damage.
IVC filters are cage-like devices made to catch blood clots before they reach the heart or lungs. Temporary, or retrievable, models such as the Option Elite have a more brittle design, leading the U.S. Food and Drug Administration (FDA) to recommend that the device be removed 29-54 days following insertion.
Retrievable IVC filters made by Argon Medical Devices, C.R. Bard, and Cook Medical have been known to tilt, migrate, perforate, or fracture, resulting in lawsuits for injuries and deaths associated with the device.
The number of lawsuits filed against IVC filter manufacturers has reached an all-time high of more than 3,000, most of which are centralized in Arizona and Illinois federal courts.
Source: Daily Hornet