MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZIV5-18-125-9-80

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

This was a case of contralateral approach to an external iliac artery.Ziv5-18-125-9-60 was attempted to be deployed, but the outer sheath came off the hub so it was taken out of the patient.((b)(4)).The user changed the wire guide from 0.014 inch to 0.018 inch and tried deploying again with ziv5-18-125-9-80, but the outer sheath came off again.((b)(4)).The procedure was completed by forcibly pulling the outer sheath of ziv5-18-125-9-80 and deploying the stent - user error.((b)(4)). the patient's anatomy was highly tortuous, which may have been a factor.3-1 was the device used percutaneously? yes.3-2 which artery was the stent to be placed in? eia (external iliac artery).3-3 was the approach ipsilateral or contralateral? (contralateral).3-4 if contralateral, was the bifurcation angle tight? yes.3-5 where on the patient was the percutaneous access site? fa (femoral artery).3-6 details of access sheath used (name, fr size, length)? medikit/parent plus 60 6fr 75cm.3-7 was the device flushed through both flushing port before the procedure, as per ifu? yes.3-8 details of the wire guide used (name, diameter, hyrdophyllic)? nipro/chevalier floopy 0.014inch hydrophilic, cordis/vassallo floopy 0.018inch hydrophilic.3-9 was the patient's anatomy tortuous or calcified? (tortuousity:yes calcification:no).3-10 was resistance encountered when advancing the wire guide or delivery system to the target location? no.3-11 how did the physician deal with this resistance? 3-12 was pre-dilation performed ahead of placement of the stent? yes.3-13 was post-dilation performed after the placement of the stent? yes.3-14 did the tip of the delivery system cross the target location? 3-15 are images of the device of procedure available? 3-16 did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? 11-1 details of the wire guide used (diameter, hydrophyllic, make)? 11-2 was high resistance encountered during stent deployment? yes.11-3 was the patient's lesion heavily calcified / was the patient anatomy tortuous? (tortuousity:yes calcification:no).11-4 was pre dilatation conducted prior to stent deployment? yes.11-5 was the stent device flushed through the flushing port(s) before the procedure, as per ifu? yes.11-6 was the delivery system damaged/kinked/twisted? yes.The outer sheath came off the hub.11-7 was the delivery system tracked around a tight angle in the patient anatomy or around a tight angle in an endoscope? yes.

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.

• Brand Name: ZILVER 518 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: 18158978
• MDR Text Key: 328430982
• Report Number: 3001845648-2023-00845
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002437880
• UDI-Public: (01)10827002437880(17)260208(10)C2021225
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV5-18-125-9-80
• Device Lot Number: C2021225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2023
• Event Location: Hospital
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• 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