FDA Warns of Safety Risks
On August 9, 2010, the FDA issued a Safety Communication regarding temporary, retrievable IVC filters. The FDA was concerned that the filters were not being removed once the patient’s risk of pulmonary embolism subsided.
At the time of the communication, the FDA had received 921 adverse event reports. Of these reports, 328 involved device migration. 146 involved broken pieces of the IVC traveling in the bloodstream, become dangerous embolisms. 70 involved the device perforating the inferior vena cava. 56 involved filter fractures.
The events may have been caused by devices remaining in a patient for long periods of time, after the risk of pulmonary embolism had subsided. In 2014, the FDA recommended retrieving the filters within 29-54 days, as long as the patient was not at risk of pulmonary embolism.
Types of IVC Filters
C.R. Bard retrievable IVC filters:
• Bard Recovery IVC Filter (withdrawn in 2005)
• Bard G2 IVC Filter
• Bard G2 Express / G2x Filter
Other retrievable IVC filters:
• Cook Günther Tulip
• Cook Celect
• B Braun Tempofilter IVC filter
• ALN IVC filter
• Rex Medical Option IVC filter