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

Model Number	G43783
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510 k#/pma: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Device wouldn¿t track over wire to desired location.Then it did not fit through a 071 id bench top catheter.No patient impact reported.
Additional Manufacturer Narrative
Device evaluation: (b)(4) unit of lot c2270691 of ziv5-18-125-8-80 was returned opened not in its original packaging.The device related to this occurrence underwent a laboratory evaluation on (b)(6) 2025.Observations from the lab evaluation were as follows.Red safety tab returned in place.Handle in pre-deployment position biological matter noted on tip of device.No other issues noted.Device flushes with no issue.0.018 inch wire guide passes through device without issue.Manufacturing records: prior to distribution all 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.Instructions for use and/label: there is evidence to suggest that the customer did not follow the instructions for use.Abnormal use complaints are considered to be beyond any further reasonable means of interface-related risk control by the manufacturer.It is unknown how the device will function outside of its intended use.Trending will monitor if any future investigation is required.As per the instructions for use, ifu0043 which informs the user about indications for use "the zilver vascular stent is intended for use as an adjunct to percutaneous transluminal angioplasty (pta) in the treatment of symptomatic vascular disease of the iliac arteries up to 100mm in length with a reference vessel diameter of 5 to 9mm.Patients should be suitable candidates for pta and/or stent treatment¿.As per medical advisor using the ziv in the venous sinus is an off-label/abnormal use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could be attributed to abnormal use.As per medical advisor using the ziv in the venous sinus is an off-label/abnormal use.It is possible that abnormal use of device may have caused the issue reported, it is unknown how the device will function outside of its intended use.Summary: complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for similar events.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 15-jul-2025.

• Brand Name: ZILVER 518 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 22077321
• Report Number: 3001845648-2025-00242
• Device Sequence Number: 18476052
• Product Code: NIO
• UDI-Device Identifier: 10827002437835
• UDI-Public: (01)10827002437835(17)280226(10)C2270691
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P050017/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: G43783
• Device Catalogue Number: ZIV5-18-125-8-80
• Device Lot Number: C2270691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2025
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 181 KG