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

Catalog Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

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

Per information received relating to (b)(4) the customer stated ¿the stent should be placed distal to an already inserted stent.Unfortunately, the transition from tip to cover was so ¿rough¿ (or there was a step here) that the stent always got stuck in the stent that was already in place.Unfortunately, this problem occurs more often with the zilver (it does not occur with the competition).In this case, we decided not to install it to be on the safe side¿ this file will capture the instances of ¿this problem occurs more often with the zilver¿ 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.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 17-apr-2024.

Manufacturer Narrative

Pma/510(k) # p050017/s006.Device evaluation the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.This file is related to pr 414274 and was opened to address feedback that this issue occurs more commonly with zilver devices than it does with competitor devices.This file will capture the instances where the issue occurs more commonly with zilver devices.Manufacturing records.Prior to distribution, all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data historical data was not reviewed as the lot number is unknown.Instructions for use and/label there is no evidence to suggest that the customer did not follow the instructions for use (ifu0058) it should be noted that the instructions for use state ¿in relation to the lesion site, the distal area of narrowing should be stented first, followed by the proximal locations (i.E., a second stent should be placed proximal to the previously placed stent)." image review an image was not returned for evaluation.Root cause analysis definitive root cause could not be determined.Possible root cause was determined to be due to advancing the device to the target site through an already placed stent.Advancing the device through the lumen of a previously placed stent risks the delivery system snagging on the struts of the already implanted stent.The users assertion that this problem is more common with zilver devices is a subjective opinion, there is no objective evidence in the file to support such a claim.Confirmation of complaint the complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary: the complaint was raised from pr (b)(4) - the catheter to which the stent is attached could not be pushed through and captures instances where ¿this problem occurs more often with the zilver¿ according to the initial reporter the stent should be placed distal to an already inserted stent.Unfortunately, the transition from tip to cover was so "rough" (or there was a step here) that the stent always got stuck in the already inserted stent.Unfortunately, this problem is more common with the zilver (does not occur with the competition).Complaint is confirmed based on customer and/or rep testimony confirmed quantity of 01 device, confirmed used 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.Investigation findings conclude a definitive root cause could not be established.A possible root cause was attributed to due to advancing the device to the target site through an already placed stent.Complaints of this nature will continue to be monitored for similar events.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18343016
• MDR Text Key: 330663157
• Report Number: 3001845648-2023-00918
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/13/2023
• Event Location: Hospital
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1