Removing Retrievable Inferior Vena Cava Filters: Initial Communication

Public:For implanting physicians and clinical care of patients with ongoing liberating vena cava filter responsible (IVC). Contains the Interventional radiologists, interventional cardiologists, vascular Surgeons, status, in the event of an emergency doctors (trauma), primary health care, orthopedic surgeons bariatric surgeons physiciansIVC filters are small, cage-like devices that have been added to the liberating vena cava (main those exported from the bottom of the heart to the body of the blood) and prevent blood clots of blood to the lungs.  IVC filters is often placed patients at risk of pulmonary embolism (blood clot, lungs) when the anticoagulant therapy cannot be used or is inoperative. Some patients may require a long-term protection of PE and implantation of permanent IVC filters are frequently in these cases. Others only in the short term, the need to protect the IVC filters are generally used in the repository, such devices must, where the option will be the patient risk PE subsidies.  IVC filter usage has increased rapidly over the last 30 years. In 1979, 2 000 IVC filters have been used, although in 2007 almost 167,000 filters were infektoituvia and IVC filters only on the market is expected to grow, with estimated 259,000 IVC filter element in 2012 (Smouse and Johar, Endovascular today February 2010). FDA has received since 2005, 921 device related to an adverse event reports, IVC filters that 328 participating device with immigration, 146 embolizations (detachment of appliance parts), 70 participating punch, IVC, 56 participating filter does. Some of these events resulted in adverse clinical outcomes, patient. These types of events may be related to the repository in the text filter for long periods of time when PE risk has subsided time exceeds the remaining.  FDA is concerned that these authorisations IVC filters, intended for a short-term location does not always removed when the patient risk PE subsides. IVC filters associated with the long-term risks are known but are not limited to the lower part of the deep's vein Thrombosis (DVT), the filter system does not burst, filter, filter embolization and migration IVC punch.FDA recommends that implanting physicians and clinical care of patients on an ongoing basis to determine how much data is actually responsible for inspection shall be carried out on the IVC filters as soon as protected from PE is a filter from a is no longer required. FDA encourages all doctors care and monitoring of the IVC filter recipients to take into account the risks and benefits of removing a filter for each patient. If the patient is available in the IVC-filter that should be removed on the basis of his individual risks and benefits of profile, primary care doctor or provide continuous patient treatment, reference should be made to remove a filter from a patient IVC when it is feasible and clinically indicated. This original communication is developing device security issues to inform the public of THE FDA's commitment. The Office shall communicate the final findings, the information available when the analysis is complete part of the development of final. As our position, THE FDA reviewed the literature and visit the quantitative decision analysis modeling to assess the risks and benefits of the profile after a change in the repository IVC filter implantation over time. For more information about the FDA's decision analysis model, including the risks and benefits of the proposals shall be adopted in accordance with the schedule for the implantation of the update for the purpose of this communication, peer review, a publication to be available in future medical journal. If, you have a communication, please contact small manufacturers Division, International and Consumer Assistance (DSMICA) at dsmica@cdrh.fda.gov or 800-638-2041. This document reflects FDA's current our commitment to the public about the ongoing safety reviews of medical devices in accordance with the examination of the facts available.