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

Catalog Number ZIV5-18-125-10-80

Device Problem Fracture (1260)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

As reported to customer relations via complaint email "i am reporting a defective product for university of (b)(6).The event took place on 11/13 and i was informed about it on 11/16.They will not be reporting this to the fda, they do not need a replacement product, you can send an acknowledgement letter to me, and i¿ll forward it on to the account.The product is not available for return.(b)(6) g43798/c2073988 physician: dr.(b)(6).Description: ¿the stent broke¿ if you can send me the follow-up questions, i will ask the customer.I was not given much detail about this incident.Are images of the device or procedure available? n/a, yes, no at what stage of the procedure did the complaint occur? unpacking or preparation of the device, insertion, stent placement, removing the introducer.Details of access sheath used (name, fr size, length)? what was the target location for the stent? was the product inspected for kinks or damage before use? n/a, yes, no was the device used percutaneously? n/a, yes, no was the device flushed through both flushing port before the procedure, as per ifu? n/a, yes, no was pre-dilation performed ahead of placement of the stent? n/a, yes, no was post-dilation performed after the placement of the stent? n/a, yes, no details of the wire guide used (name, diameter, hyrdophyllic)? did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? n/a, tortuous, calcified, altered was resistance encountered when advancing the wire guide to the target location? n/a, yes, no was resistance encountered when advancing the delivery system to the target location? n/a, yes, no how did the physician deal with this resistance? was the approach ipsilateral or contralateral? n/a, ipsilateral, contralateral if contralateral, was the bifurcation angle steep? n/a, yes, no did the tip of the delivery system cross the target location? n/a, yes, no was the delivery system tracked around a tight angle in the patient anatomy? n/a, yes, no was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no was the handle pulled towards the hub during deployment? n/a, yes, no was the delivery system pushed during deployment? n/a, yes, no was the stent deployed smoothly / without resistance? n/a, yes, no if no, please detail any difficulty experienced during deployment: what artery was the stent placed in? was the stent fully deployed from the delivery system prior to removal of the delivery system? n/a, yes, no did the patient have any pre-existing conditions? n/a, yes, no if yes, please specify: did the patient require any additional procedures as a result of this event? n/a, yes, no what intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no please specify if 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.

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

Supplemental report is being submitted due additional information received on 13-jan-2024: gpn has been updated based on the udi.Rpn corrected to ziv5-18-125-10-80.

• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 18319680
• MDR Text Key: 330393739
• Report Number: 3001845648-2023-00902
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ZIV5-18-125-10-80
• Device Lot Number: C2073988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/13/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• 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