Pma/510(k) # p050017/s002 and s003.(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).This follow up report is being submitted due to the completion of the investigation into this event and the conclusion of this investigation.The ziv5-18-125-8-40 device of lot number c1384818 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.From customer testimony, the physician removed the safety tab while the distal tip of the delivery system was still in the 6fr access sheath.This indicates that the device was still being advanced to the target location.Removal of the safety tab prior to reaching the target lesion is against the instructions for use, and could have caused or contributed to the premature deployment in the access sheath.However, as the device is not available and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.The following is stated in the product instructions for use: ¿ensure that the red safety lock is not removed until ready for final stent release.¿ prior to distribution all zilver 518 vascular devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1384818.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with another device.Complaints of this nature will continue to be monitored for potential emerging trends.
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