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

Catalog Number ZIV6-125-6-8.0

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

A kink was observed on the outer sheath prior to use but the user proceeded to advance the kinked device and attempt to deploy it in the patient.(user error) this file related to (b)(4)".A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) #p050017 s002 and s003.The ziv6-125-6-8.0 device of lot number c1649233 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.On evaluation of the device a slight kink was observed approximately 23 cm from the white connector cap on the outer sheath.The stent had partially deployed at the distal end of the outer sheath at the distal white tip.The device flushed as expected and a 0.035¿ wire guide passed through the device without issue.Prior to distribution ziv6-125-6-8.0 devices are subjected to a visual inspection and functional checks to ensure device integrity.Integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for ziv6-125-6-8.0 of lot number c1649233 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 c1649233.It should be noted that the instructions for use states the following: procedure access 1.Upon removal from the package, inspect the product to ensure no damage has occurred.There is evidence to suggest the user did not follow the instructions for use as according to the customers testimony a kink was observed on the outer sheath prior to use but the user proceeded to advance the kinked device and attempt to deploy it in the patient a definitive root cause of user error was identified from the available information.The instructions for use direct the user to inspect the product for damage prior to use.A kink was observed on the outer sheath prior to use but the user proceeded to advance the kinked device and attempt to deploy it in the patient.The information provides also reveals that the patient exhibited tortuous anatomy.The kink observed in the outer sheath prior to use together with the patients tortuous anatomy may account for the resistance encountered when advancing the delivery system to the target 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.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.Initial report details: a kink was observed on the outer sheath prior to use but the user proceeded to advance the kinked device and attempt to deploy it in the patient.(user error).This file related to (b)(4) - mdr reference# 3001845648-2021-00151.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11379015
• MDR Text Key: 233555550
• Report Number: 3001845648-2021-00149
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002336589
• UDI-Public: (01)10827002336589(17)220916(10)C1649233
• 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: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2022
• Device Catalogue Number: ZIV6-125-6-8.0
• Device Lot Number: C1649233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2021
• Event Location: Hospital
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 57