The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the stent had prematurely deployed and was noted to be deformed.Functional testing could not be performed due to the condition of the device.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Based on the information available, it is likely excessive force was applied to the device while advancing through the microcatheter.Therefore, a cause of user error will be assigned to the investigation.
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