Christine G., a New Mexico resident, has filed a lawsuit against Rex Medical and Argon Medical Devices over their Option Elite inferior vena cava (IVC) filter last December after the filter tilted and was unable to be retrieved.
The Option Elite IVC filter is a retrievable model recommended by the FDA to be removed 29 to 54 days after insertion, due to the high risk of tilting, fracturing, perforating and migrating. Although Christine’s was placed temporarily to protect against blood clots in her lungs, the removal attempt wasn’t until a year after insertion.
Christine received her filter in May 2015 at Lovelace Medical Center in Albuquerque, New Mexico. In April 2015, her doctor attempted to remove the filter, but found it to be tilted. After several unsuccessful attempts to snare the hook of the filter, the doctor gave up.
Another doctor attempted to remove the filter in October 2016, encountering complications because the filter was “deeply embedded in her inferior vena cava,” according to the suit. The removal was successful, however.
The Option Elite IVC filter model was approved by the FDA without clinical trials by way of a 410 (k) approval, meaning it was similar enough to previous devices already sold on the market, such as C.R. Bard’s Recovery and G2. Both of Bard’s filters have been linked to a 40 percent risk of fracturing within a five-year time frame. The Recovery and G2 have also been linked to hundreds of injuries and many deaths.
Source: Daily Hornet