Bard G2 IVC Filter

IVC-Filter

What Are IVC Filters?

Inferior vena cava (IVC) filters are small medical devices shaped like spiders. They are designed to catch blood clots and prevent them from migrating to the lungs, where they could cause a pulmonary embolism. The Bard Recovery and G2 filters were designed to be retrievable, but have been linked to numerous injuries and complications over the last few years. Common complications with IVC filters left in the body for long periods of time includes:

  • Recurrent PEs
  • Filter migration or movement
  • Tilting or breaking of the IVC filter
  • IVC perforation or occlusion

According to the FDA, the majority of IVC filters are not retrieved, and their benefits have made them a frequent choice for doctors and patients, despite their perceived risk of increased fracture, embolism, and IVC wall penetration.

Device manufacturers’ first responsibility is to the safety of the people using their product – it is up to them to ensure that a medical device is fit for use by the public.

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.

Scientific Study of Bard IVC Filter

A study published in the Archives of Internal Medicine showed a high rate of fractures and fragment embolization in patients who received retrievable IVC filters manufactured by C.R. Bard.

The study was prompted when Dr. William Nicholson received one patient who had suffered chest pain, fluid build-up around the heart, and perforation of the right ventricle caused by the Bard IVC filter. After reviewing this case, Dr. Nicholson asked all 80 of his patients who had been implanted with a Bard IVC filter come into the clinic for an exam.

Though the study appeared to show that the newer Bard IVC filter had a lower fracture rate, this may be due to the fact that the rate of complications increases over time.

Risks & Complications

  • The filter could move, migrate, or change position, and become stuck in a place where it is not designed to be. This could cause it to become ineffective, or cause damage to internal organs.
  • The filter could perforate or erode into the inferior vena cava, causing damage to this vein. It could also protrude and damage internal organs.
  • Parts of the filter can break off, travel in the bloodstream, and severely damage the heart or lungs
  • The filter may become clogged with clots, which could block the flow of blood from the lower body into the heart
  • Damage to the heart, lungs, inferior vena cava, or other internal organs.
  • A doctor may be unable to take out the IVC filter

Bard IVC Filter Side Effects

  • Perforation of the inferior vena cava, heart, or lungs
  • Filter fracture
  • Filter migration
  • Chest pain
  • Hemorrhagic pericardial effusion (excess fluid around the heart)
  • Cardiac tamponade (compression of the heart caused by excess fluid around the heart)
  • Lower-limb Deep Vein Thrombosis (DVT)
  • Filter embolization

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