July 23, 2015 — C.R. Bard has received a warning letter from the FDA for failing to inform the agency of IVC filter malfunctions, misfiling reports of injuries and deaths as “malfunctions,” and manufacturing a device without approval.
Violations were observed during inspections of a facilities in New York and Arizona from beginning in October 2014.
The FDA learned that the Bard Recovery Cone Removal System was sold without marketing clearance or approval from the FDA. The device is used to retrieve temporary IVC filters, including the Recovery, Recovery G2, and G2X filters, but was not cleared for use with those devices.
The FDA also found that Bard misfiled numerous reports as “malfunctions” when they were actually very serious injuries or deaths.
Several reports involved broken filters that perforated the vena cava, caused pericardial effusion, or had to be removed surgically. In one case, a G2 Filter broke and the detached filter arm caused hemorrhage and necrosis in a patient’s right lung, resulting in death.
Many of these complications were included in a Safety Communication issued by the FDA in 2010. Since 2005, the agency had received nearly 1,000 reports of patients who were injured by temporary IVC filters that were not removed as soon as they were no longer necessary, including
- Device migration (328 reports)
- Embolizations or detachment of components (146 reports)
- Perforation of the vena cava (70 reports)
- Filter fracture (56 reports)
In February 2012, a study found an overall 12% fracture rate for the Bard Recovery, G2, and G2 Express IVC filters. Unfortunately, only 53% of fractured components were successfully recovered.
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