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IVCフィルターに関する安全性情報

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  IVCフィルターのトラブルについて検索していたところ、先日米国FDAから、IVCフィルターに関する安全性情報が出されていましたので、ご紹介します。

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Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use [Posted 08/09/2010]

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.

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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.
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  2005年以降、921件のトラブル報告があり、深刻な有害事象も発生しているようです。FDAでは、肺塞栓症の危険性が少なくなった時点でのフィルター除去をすすめています。また、その判断には挿入した医師が責任を負うべきだと報告しています。

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