MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number	G43867
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Pma/510(k) #p050017/s002 and s003.The ziv6-35-80-10-60 device of lot number c1158108 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.The customer was contacted to request additional information.At the time of the investigation, the information was not yet provided.The investigation will be updated once the information has been provided.There is no evidence to suggest this event did not occur.Therefore, the customer complaint is confirmed based on customer testimony.Possible causes for this occurrence could include a difficult patient anatomy.A severely calcified or tortuous anatomy could create resistance during advancement, causing or contributing to the inability to pass the device through the lesion.However, the device was not returned for evaluation, the information has not yet been provided and the circumstances of use cannot be replicated in a laboratory environment.Therefore, a definitive root cause for this occurrence cannot be determined.Prior to distribution all ziv6 (zilver 635) 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 c1158108.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
Evt of the eia was performed by contralateral approach from cfa.Although the physician attempted to make the delivery system of the complaint ziv6-35-80-10-60 pass through the lesion, it would not.The procedure was cancelled.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6861341
• Report Number: 3001845648-2017-00391
• Device Sequence Number: 11068583
• Product Code: NIO
• UDI-Device Identifier: 10827002438672
• UDI-Public: (01)10827002438672(17)181010(10)C1158108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: G43867
• Device Catalogue Number: ZIV6-35-80-10-60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1