As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the reported material deformation and positioning failure.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model 5f061003c vascular stent allegedly experienced material deformation, and positioning failure.This information was received from one source.The one reported malfunction involved one patient with no consequences.The age, sex and weight of the patient was not provided.
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