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

Model Number	G43851
Medical Device Problem Code	Delivery System Failure (2905)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2017
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 investigation into this event is still being carried out.A follow up report will be submitted with the investigation conclusions.
Event or Problem Description
The actual black covering of the zilver released from the white hub, the stent was deployed with some difficulty as this occurred mid deployment.
Additional Manufacturer Narrative
Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.(b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) # p050017/s002 and s003.This follow up report is being submitted due to the completion of the investigation into this event and the conclusion of this investigation.The ziv6-35-80-7-40 of lot c1327564 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.From customer testimony, it is known that the complaint device was advanced over a cook amplatz wire guide of 0.035¿ diameter (part number thsf-35-180-aus).It is not known if the device was flushed, or if pre-dilation was conducted prior to use.Details of the patient¿s anatomy are unknown.It is unknown if handle was pulled towards the hub during deployment.The stent was fully deployed in the patient, with difficulties.The cook representative was contacted to provide information, but at the time of investigation the information was not available after three requests.The investigation will be updated if the information is provided.On evaluation of the returned device, it was observed that the flexor had separated from the handle at the white cap.There was no tactile damage on the flexor.The device was returned with the stent already deployed.The flexor was measured as 81cm, which was within specification of 80cm +1.3cm -0.8cm.The customer complaint is confirmed, as the flexor was observed to be separated from the handle.Possible causes for this occurrence could include a difficult patient anatomy.The patient anatomy could have caused high deployment forces during the use of the product.These forces could have caused or contributed to the flexor separating from the handle.However, as the conditions of use cannot be replicated in a laboratory environment and the information has not yet been provided, a definitive root cause for this occurrence cannot be determined.It may be noted that a project has been initiated to prevent the reoccurrence of outer sheath separation from the handle.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 any issues with lot c1327564.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
This follow up report is being submitted due to the completion of the investigation into this event and the conclusion of this investigation.Initial report details: the actual black covering of the zilver released from the white hub, the stent was deployed with some difficulty as this occurred mid deployment.

• 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: 6717012
• Report Number: 3001845648-2017-00274
• Device Sequence Number: 16393529
• Product Code: NIO
• UDI-Device Identifier: 10827002438511
• UDI-Public: (01)10827002438511(17)200217(10)C1327564
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/17/2017

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: G43851
• Device Catalogue Number: ZIV6-35-80-7-40
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/17/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1