MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number	G43781
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # p050017/s002 and s003.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations: "when the dr.Unlocked the device the zilver 518 vascular self-expanding stent started to deploy inside the 6fr sheath.The stent did not deploy inside the patient.The device was removed and another device was used for the procedure.".
Additional Manufacturer Narrative
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.
Event or Problem Description
This follow up report is being submitted due to the completion of the investigation into this event and the conclusion of this investigation.As reported to customer relations: "when the dr.Unlocked the device the zilver 518 vascular self-expanding stent started to deploy inside the 6fr sheath.The stent did not deploy inside the patient.The device was removed and another device was used for the procedure.".

• Brand Name: ZILVER 518 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7153773
• Report Number: 3001845648-2017-00626
• Device Sequence Number: 16639046
• Product Code: NIO
• UDI-Device Identifier: 10827002437811
• UDI-Public: (01)10827002437811(17)200803(10)C1384818
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G43781
• Device Catalogue Number: ZIV5-18-125-8-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1