Product analysis summary: the device returned to medtronic for evaluation.Kinks were evident on the hypotube.The stent was positioned on the balloon between the marker bands as per position specification, but due to proximal and mid stent deformation the stent did not meet visual acceptance specification.Deformation was evident to the proximal and mid stent wraps with struts raised and bent.The inner member was kinked under the mid stent deformation.No deformation was evident to the distal tip.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood.No other damage evident to the remainder of the device.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
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