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

Catalog Number ZIV6-35-125-8-40

Device Problem Migration (4003)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

Per email on 15mar2024: reported stent ¿jumped¿ upon deployment.Patient/event info - notes: the following information has been requested via email on 18mar2024 / 29mar2024 / 08apr2024.Sg 08apr2024 1.Contact at facility and contact info: 2.Will the facility be reporting this to a government agency (fda, competent authority, etc.) 3.Will the product be returned? a.If yes a return label will be provided.4.Usage of product (please select only one below): a.Initial use of device b.Reuse of device c.Unknown 5.Was product reprocessed for reuse prior to occurrence? 6.Description of event: 7.Can you provide any patient information (age, weight, gender, pre-existing conditions)? 8.What type of procedure was being performed? 9.Did the event result in a death? 10.Did any unintended section of the device remain inside the patient¿s body? a.If yes, please describe.11.Was the patient hospitalized or was there prolonged hospitalization? 12.Did the patient require any additional procedures due to this occurrence? 13.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify additional procedures and provide details.14.Has the complainant reported any adverse effects on the patient due to this occurrence? 15.Has the complainant reported that the product caused or contributed to the adverse effects? a.Please specify adverse effects and provide details.16.How was the procedure able to be completed? 17.Are images of the device or procedure available? 18.At what stage of the procedure did the complaint occur? a.Insertion b.Stent placement c.Removing the introducer.19.Details of access sheath used (name, fr size, length)? 20.What was the target location for the stent? 21.Was the product inspected for kinks or damage before use? 22.Was the device used percutaneously? 23.Was the device flushed through both flushing port before the procedure, as per ifu? 24.Was pre-dilation performed ahead of placement of the stent? 25.Was post-dilation performed after the placement of the stent? 26.Details of the wire guide used (name, diameter, hyrdophyllic)? 27.Did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? n/a, tortuous, calcified, altered 28.Was resistance encountered when advancing the wire guide to the target location? 29.Was resistance encountered when advancing the delivery system to the target location? 30.How did the physician deal with this resistance? 31.Was the approach ipsilateral or contralateral? n/a, ipsilateral, contralateral a.If contralateral, was the bifurcation angle steep? 32.Did the tip of the delivery system cross the target location? 33.Was the delivery system tracked around a tight angle in the patient anatomy? 34.Was the delivery system damaged/kinked/twisted during deployment? 35.Was the handle pulled towards the hub during deployment? 36.Was the delivery system pushed during deployment? 37.Was the stent deployed smoothly / without resistance? a.If no, please detail any difficulty experienced during deployment: 38.What artery was the stent placed in? 39.Was the stent fully deployed from the delivery system prior to removal of the delivery system? 40.What intervention (if any) was required? 41.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 42.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? a.Please specify if yes **please provide the originator a list of any additional manufacturer questions required for investigation.Sg 18mar2024.

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 635 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: 19077417
• MDR Text Key: 340700248
• Report Number: 3001845648-2024-00166
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002438313
• UDI-Public: (01)10827002438313(17)241013(10)C1876347
• Combination Product (y/n): N
• 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: 03/15/2024

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: ZIV6-35-125-8-40
• Device Lot Number: C1876347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2024
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1