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

Model Number	G43791
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the physician deployed the stent; however, a portion of it was positioned incorrectly.The device representative indicated that there were no defects or issues with the stent itself.The physician performed a wire exchange prior to advancing the stent; however, the guidewire inadvertently tracked into an unintended pathway.As a result, when the stent was deployed, it was not positioned as expected.The stent itself functioned as intended.Patient was reported fine.Can you clarify what exactly is meant in the description of event: ¿¿a portion of the stent was positioned incorrectly.¿ does this mean that a use error may have occurred and if so, what part of the ifu would this refer to? the physician performed a wire exchange prior to advancing the stent; however, the guidewire inadvertently tracked into an unintended pathway.As a result, when the stent was deployed, it was not positioned as expected.The stent itself functioned as intended.What was the target location for the stent? the intended target location for the stent is unknown, as the device was used off-label.What disease pathology was being treated? unknown, as the device was used off-label.Was the device used percutaneously? yes.What intervention (if any) was required? none.Was post dilation performed after the placement of the stent? no.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: ZILVER 518 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• 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: 25115777
• Report Number: 3001845648-2026-00170
• Device Sequence Number: 9292479
• Product Code: NIO
• UDI-Device Identifier: 10827002437910
• UDI-Public: (01)10827002437910(17)281112(10)C2365747
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: G43791
• Device Catalogue Number: ZIV5-18-125-10-40
• Device Lot Number: C2365747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2026
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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 Sex: Unknown