トミザワ　ヤスコ   TOMIZAWA Yasuko   冨澤　康子    所属   その他 その他    職種   非常勤嘱託
論文種別	総説
言語種別	英語
査読の有無	査読あり
表題	Intravascular foreign bodies: danger of unretrieved fragmented medical devices.
掲載誌名	正式名：Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs 略　 称：J Artif Organs ISSNコード：14347229/16190904
掲載区分	国内
出版社	Springer Japan
巻・号・頁	12(2),pp.80-89
著者・共著者	TATEISHI Minori†, TOMIZAWA Yasuko
発行年月	2009/08
概要	A warning on the danger of unretrieved device fragments and recommendations to mitigate the danger were issued by the Food and Drug Administration in January 2008. The causes of intravascular foreign bodies are classified into three main categories: improper manipulation and usage, device defects, and others, such as patient and anatomical factors. Device failure after long-term use is rarely predicted at the time of approval, since device abnormality is rarely experienced in animal studies and clinical trials conducted during development of the device. Stent fracture due to metal fatigue is one example. Complex complications could occur from simultaneous use of two or more devices with diverse characteristics. The success rate of percutaneous retrieval of intravascular foreign bodies has improved with the advances in commercially available devices. However, the procedure is not always successful and sometimes surgical removal becomes necessary. Appropriate device selection and acquisition of experience in using the device are important. When an intravascular foreign body cannot be retrieved, the risk of complication could be high. Magnetic resonance imaging examination sometimes causes adverse events, including burns due to the heat generated by metal movement. Such information should be correctly recorded. Furthermore, it is necessary to provide patients with adequate information about the characteristics of implanted devices and unretrieved fragments. We reviewed the literature on unretrieved medical device fragments and include articles that describe the Japanese experience.
DOI	10.1007/s10047-009-0447-6
PMID	19536624