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

Model Number	G43777
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Device received but remains under investigation.
Event or Problem Description
A patient of undisclosed age and gender underwent an unspecified procedure in which the zilver 518 vascular self-expanding stent, g43777, was used.The hub of the detachment part on the catheter came apart from the sheath and the catheter would not deploy/detach.They pulled the red safety tab, had some resistance when trying to pin pull.They did admit it may have been user error- was unnecessarily forceful with the black hub.They were able to safely remove the defective zilber and place a new zilver successfully.No issues with patient and no additional measures were necessary.The device was inspected prior to use, and no damage was seen.The target location for the stent was the transverse venous sinus (off ifu) to treat the disease pathology of idiopathic intracranial hypertension (iih).Pre-dilation was not performed ahead of stent placement.An asahi wire guide was used during the procedure.The patient had no stents previously placed during prior procedures but did exhibit difficult, tortuous anatomy.No resistance was encountered when advancing the delivery system to the target location.

• 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
• 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: 25191574
• Report Number: 3001845648-2026-00183
• Device Sequence Number: 10384852
• Product Code: NIO
• UDI-Device Identifier: 10827002437774
• UDI-Public: (01)10827002437774(17)280818(10)C2333485
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 06/17/2026

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: G43777
• Device Catalogue Number: ZIV5-18-125-7-60
• Device Lot Number: C2333485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2026
• 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): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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: 29 YR
• Patient Sex: Female