It was reported that the procedure was to treat a de novo lesion located in the heavily tortuous, mildly calcified, 85% stenosed, distal common carotid artery.The 10tx30x136 xact stent delivery system (sds) reached the target lesion; however, the stent implant could not be released.Resistance was felt during advancement of the sds to the lesion and the shaft (outer member) separated during use.The device was changed for another sds and the procedure was completed successfully.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
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(b)(4).Evaluation summary: the device was returned for analysis.The failure to deploy was not able to be confirmed as the stent was not returned.The reported separation of the shaft was confirmed.The resistance could not be confirmed as it was based on case circumstances.Based on a visual and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other incidents for failure to deploy, resistance or separation reported from this lot.Based on the reviewed information, no product deficiency was identified.
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