MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZFV6-80-10-8.0

Device Problems Off-Label Use (1494); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The stent was deployed while pulling back stent assembly, it got stuck & could not be puled out, finally with force stent deformed.

Manufacturer Narrative

Pma/510(k) #: p050017/s006.The zfv6-80-10-8.0 device of lot number c1690973 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Prior to distribution zfv6-80-10-8.0 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zfv6-80-10-8.0 of lot number c1690973 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current 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 c1690973.It should be noted that the instructions for use states the following: ¿intended use the product is intended for use in the iliac, superficial femoral artery (sfa) and above-the-knee popliteal artery for the following treatments: ateriosclerotic stenosis, total occlusions that have been recanalized.¿ there is evidence to suggest the user did not follow the ifu.A definitive root cause of off-label use was identified from the available information.From the information provided it is known that the target location for the device was the common bile duct (cbd).As per the ifu the device is intended for use in the iliac, superficial femoral artery (sfa) and above-the-knee popliteal artery.The additional information confirms that the device was kinked during the procedure.Off-label use of the device may have resulted in the device becoming kinked during advancement or attempted deployment.The kink on the device may have contributed to increased resistance during attempted deployment.Use of the device in a location that is not indicated for use may have resulted in the user being unable to deploy the stent.From the information provided it is known that the user deployed the stent using excessive force.The stent deformed on deployment as a result of the excessive for required to complete deployment in a non-recommended location.The complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.However, an additional stent had to be placed during the same procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11208326
• MDR Text Key: 232625718
• Report Number: 3001845648-2021-00036
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002519333
• UDI-Public: (01)10827002519333(17)221212(10)C1690973
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Catalogue Number: ZFV6-80-10-8.0
• Device Lot Number: C1690973
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/24/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention