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

Catalog Number ZIV6-125-8-4.0

Device Problems Device Damaged Prior to Use (2284); Activation, Positioning or Separation Problem (2906)

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

Event Date 06/08/2023

Event Type  malfunction  

Event Description

It was found that the stent had been released and was not in the delivery sheath when the user opened the packaging.The procedure was completed by using another new device,no adverse effect reported.The procedure was completed by using another new device,no adverse effect reported.

Manufacturer Narrative

Pma 510k #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 to the completion of a lab evaluation on 18-jul-2023.

Manufacturer Narrative

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

Manufacturer Narrative

Pma 510k # p050017/s002 and s003.Device evaluation: the ziv6-125-8-4.0 device of lot number c1778937 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation.On evaluation of the device the following was noted: visual inspection: red safety tab not returned.Kink observed below the white connector cap.Stent returned separately and intact.Functional inspection.Devices flushes with no issue.0.035'' wire passes with no issue.This is the required wire guide size for this device.Photographs were also received through the complaint process.Upon evaluation of these 2 photographs, the following was noted: deployed stent outside of delivery system.Red safety tab cannot be seen.Manufacturing records: prior to distribution all zilver devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Throughout the manufacturing process, all products undergo numerous quality checks to ensure product quality and conformance.These checks are outlined in quality procedure qsi0975.These checks are performed at: production, final quality control, packaging, packaging qc , post sterilisation qc, post sterilisation services, foil packaging qc and post sterilisation services.These checks include: - complete a 100% visual inspection of a unit while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions for all units in a reasonable amount of time.- an initial 100% visual inspection of any individual component or combination of components (e.G., product, pouch, tray, label, ifu, instruction leaflet, implant card, etc.) should be completed prior to commencing the relevant packaging instruction.- complete a 100% visual inspection of the packaged unit while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions.Therefore it is highly unlikely that the device left the manufacturing plant, with the stent deployed inside the packaging.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use/label: it should be noted that the instructions for use (ifu0041) states the following: ¿upon removal from the package, inspect the product to ensure no damage has occurred¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review.An image was not returned for evaluation.Root cause review.A definitive root cause could not be determined from the available information.A possible root cause of impact during transportation could be identified from the available information.The stent was found to be deployed when the user was unpacking the device.It was observed in the lab evaluation that the red safety tab was not present.The user was asked if the red safety tab was present when the device was unpacked or had that also been dislodged but they could not recall.They stated that because the product was not used, it was not noticed whether the safety tab was removed.It is possible that impact received during transportation could have caused the red safety tab to be knocked out resulting in the stent becoming deployed.It was also observed during the lab evaluation, that there was a kink present below the white connector cap on the device.The photographs that were submitted with the complaint, showed the device when the issue of the stent prematurely being released was noted first, and there was no visible kinks present on the device.The user was asked if the kink seen in the lab, was present on the device prior to return but they replied that as the device was not being used, it was removed from the operating table and wasn't checked for damage.Based on the images provided by the customer of the complaint issue, which show no kink beneath the white connector cap, this damage has been attributed to returns transportation as the device was being returned to cook ireland for evaluation.Confirmation of complaint.Complaint is confirmed based on customer and/or rep testimony.Summary.According to the initial reporter, it was found that the stent had been released and was not in the delivery sheath when the user opened the packaging.Confirmed quantity of (b)(4) device, confirmed prior to use.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.This occurred prior to patient contact and another device was used to carry out the procedure.Investigation findings conclude definitive root cause could not be determined.Possible root causes could be attributed to impact during transportation that possibly could have dislodged the red safety tab and resulted in the stent becoming partially deployed complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 13-feb-2024.

• 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: 17403560
• MDR Text Key: 319827557
• Report Number: 3001845648-2023-00583
• Device Sequence Number: 1
• Product Code: NIO
• 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,Followup,Followup
• Report Date: 02/13/2024

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 Expiration Date: 11/23/2023
• Device Catalogue Number: ZIV6-125-8-4.0
• Device Lot Number: C1778937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 06/28/2023; 06/28/2023
• Supplement Dates FDA Received: 08/15/2023; 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2020
• 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