| Endovascular stents: market vigilance and risk factors. | |
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MedLine Citation:
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PMID: 14984183 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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With the aim of enhancing the safety and reliability level of coronary stents, we analyzed data collected from accident reports drawn from the MAUDE database (Manufacturer and User Facility Device Experience Database) of the FDA from 1996 to 2000. This analysis allowed us to highlight problems related to the use of coronary stents by means of the analysis of these reports at different levels, beginning from the causes that can lead to a certain type of accident up to the possible complication related to that event. Moreover we analyzed the procedure outcomes in terms of stent position inside the patient's body and the possible therapies adopted to solve the problems. The results showed that the most probable event that can lead to an accident is the stent separation from the balloon which, alone, turns up in a number of cases equal to the sum of all the others. This result highlights the importance of the technical skill of the operators accomplished by special training and of the importance of clarity and completeness in the instructions for the use of the device. Another critical point is the reliability of the device which must guarantee an adequate safety level when it is used according to the instructions. |
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Authors:
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M Grigioni; C Daniele; M Abbate; G D'Avenio; U Morbiducci; C Del Gaudio; V Barbaro |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: The International journal of artificial organs Volume: 27 ISSN: 0391-3988 ISO Abbreviation: Int J Artif Organs Publication Date: 2004 Jan |
Date Detail:
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Created Date: 2004-02-26 Completed Date: 2004-05-19 Revised Date: 2005-11-16 |
Medline Journal Info:
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Nlm Unique ID: 7802649 Medline TA: Int J Artif Organs Country: Italy |
Other Details:
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Languages: eng Pagination: 45-54 Citation Subset: IM |
Affiliation:
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Laboratory of Biomedical Engineering, Istituto Superiore di Sanità, Roma, Italy. grigioni@iss.it |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Angioplasty, Transluminal, Percutaneous Coronary
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adverse effects Coronary Disease / therapy* Humans Risk Factors Stents / adverse effects* Treatment Outcome |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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