It was reported that during stent deployment, the rx acculink 7.0 x 30mm stent was deployed in the left carotid artery, but was misplaced and did not fully cover the lesion.A second stent was implanted to fully cover the lesion.There was no adverse patient sequela and no clinically significant delay in procedure reported.One day post procedure, the patient was discharged home.There was no additional information provided.
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(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.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 similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.
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