TOMIZAWA Yasuko
   Department   Other, Other
   Position  
Article types Review article
Language English
Peer review Peer reviewed
Title Intravascular foreign bodies: danger of unretrieved fragmented medical devices.
Journal Formal name：Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs
Abbreviation：J Artif Organs
ISSN code：14347229/16190904
Domestic / ForeginDomestic
Publisher Springer Japan
Volume, Issue, Page 12(2),pp.80-89
Author and coauthor TATEISHI Minori†, TOMIZAWA Yasuko
Publication date 2009/08
Summary 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