Endovascular stents: market vigilance and risk factors.
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.
Laboratory of Biomedical Engineering, Istituto Superiore di Sanità, Roma, Italy. grigioni@iss.it
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Grigioni
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Daniele
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Abbate
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D'Avenio
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Morbiducci
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Del Gaudio
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Barbaro
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D003327:Coronary Disease / Q000628:therapy*; D006801:Humans; D012307:Risk Factors; D015607:Stents / Q000009:adverse effects*; D016896:Treatment Outcome