The lot number for the device was provided, therefore a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The pro code for the lifestent 5f vascular stent system products is identified.
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This report summarizes one malfunction.A review of the reported information indicated that model 5f061003c vascular stent allegedly experienced positioning problem.This information was received from one source.This event involved one patient with no patient consequences.Age, weight, and gender were not provided.
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