Pharmaceutical

Retrievable IVC Filters may fracture if not removed as prescribed

IVC filter 294x210 Retrievable IVC Filters may fracture if not removed as prescribedFollowing a car accident, a 33-year-old man was brought to the Boston Medical Center (BMC), New England’s largest trauma center. He received an inferior vena cava (IVC) filter, a retrievable model called the G2 made by C.R. Bard. He was not advised of needed follow-up care, and returned to the hospital five years later with chest pains.

Upon further testing, the medical team discovered that his IVC filter had fractured, and a strut of the filter had been lodged in a pulmonary artery. He underwent a fluoroscopic procedure, successfully retrieving the broken strut as well as the filter before it could do any more damage.

Another patient, age 56, was also admitted to BMC following a car accident. When he developed a pulmonary embolism (PE), an Eclipse IVC filter, also made by C. R. Bard, was put into place. Afterward, his hemoglobin level dropped. Imaging revealed that the IVC filter had perforated the vein and caused an internal bleed. Only nine days after the filter was placed, a medical team attempted to retrieve it, but was unsuccessful. When the bleeding stabilized, the patient was discharged with blood thinning medication, the IVC filter still in place, rendered irretrievable.

An IVC filter is a device closely resembling a spider that is placed in the largest vein in the body. They are designed to catch blood clots before they reach the heart or lungs, preventing pulmonary embolism. They’re often used for patients who cannot tolerate blood-thinning medication.

According to the FDA, retrievable IVC filters should be removed between 29 and 54 days after insertion. If the device is left in the body any longer, the patient is at increased risk of the filter migrating, fracturing, tilting or perforating.

Medical device manufacturers such as C.R. Bard, Johnson & Johnson’s subsidiary Cordis, and Cook Medical are facing more than 2,500 lawsuits alleging IVC filters have failed, inflicting injury or death.

Source: Jama Network