Excerpts from a July 13, 2015 Letter from the FDA to Bard Medical:
FDA has learned that your firm manufactures the Recovery Cone Removal System, Model RC-15 in the United States without marketing clearance or approval, in violation of the Act. Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body. As explained below, this device is being marketed without the required clearance or approval.
FDA has also learned that your firm manufactures the Recovery Cone Removal System, Model FBRC in the United States without marketing clearance or approval, in violation of the Act. Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body. As explained below, this device is being marketed without the required clearance or approval.
Complaint (b)(4) for a G2 Filter, embolization of a detached filter arm with associated areas of hemorrhage and necrosis in the right lung was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death. The following complaints were filed as malfunctions and should have been filed as serious injuries: Complaint (b)(4), Eclipse Filter, detached filter limb resulting in pericardial effusion and cardiac catheterization; (b)(4), G2 Express Filter, broken filter and surgical intervention; (b)(4), Denali Jugular System, detached filter arm embedded in IVC wall with filter retrieval; (b)(4), G2 Filter, detached filter limb in renal vein with IVC wall perforation and blood thinner treatment; (b)(4), G2 Express Filter, IVC perforation and aneurysm; (b)(4), G2 Filter, abdominal pain with filter legs protruding through IVC wall and percutaneous removal; (b)(4), G2 Filter, abdominal pain with filter legs perforating IVC wall, partial retrieval and residual filter leg fragment embedded in IVC wall.
FDA Safety Communication: Removing Retrievable Inferior Vena Cava Filters
May 6, 2014
Audience: Physicians who implant inferior vena cava (IVC) filters and clinicians responsible for the ongoing care of patients with these devices.
Medical Specialties: Interventional radiology, interventional cardiology, vascular surgery, trauma care, bariatric surgery, orthopedic surgery, primary care
IVC filters are small, cage-like devices that are inserted into the inferior vena cava to capture blood clots and prevent them from reaching the lungs. The inferior vena cava is the main vessel returning blood from the lower half of the body to the heart. IVC filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when anticoagulant therapy cannot be used or is ineffective. IVC filters are designed to be permanent implants although some of these devices may have the option to be removed.
Purpose: The Food and Drug Administration (FDA) is updating a previously issued Initial Communication to include information on recently published research and postmarket surveillance studies for these devices.
Summary of Problem and Scope:
The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.
The FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.
The FDA encourages all physicians involved in the treatment and follow-up of patients receiving IVC filters to consider the risks and benefits of filter removal for each patient. A patient should be referred for IVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient’s health status.
The FDA developed a quantitative decision analysis using publicly available data available in the medical literature to assess whether there is a time period during which the risk of having an IVC filter in place is expected to outweigh the benefits. The decision analysis (Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients without Pulmonary Embolism) was published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders in October 2013. The mathematical model suggested that if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.
Although the results of the decision analysis provide important insight for retrievable IVC filters, the FDA is requiring collection of additional clinical data for currently marketed IVC filters in the United States. The studies will address safety questions that remain unanswered for both permanent and retrievable filters. Manufacturers were given two options for obtaining the data. Some manufacturers are participating in the PRESERVE(PREdicting the Safety and Effectiveness of InferioR VEna Cava Filters) study, an independent national clinical study that will examine the use of IVC filters in the prevention of pulmonary embolism. Other manufacturers are conducting postmarket surveillance (522 Studies). The data gathered from the PRESERVE study and the 522 studies will help the FDA, manufacturers and health care professionals assess the use and safety profile of these devices, understand evolving patterns of clinical use of IVC filters and ultimately improve patients care.
Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use
AUDIENCE: Emergency Medicine, Surgery
ISSUE: Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided.
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
BACKGROUND: FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about FDA’s decision analysis model including risk/benefit implantation timeframe suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal.
RECOMMENDATION: FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed.
FDA encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated.