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

Model Number	G43788
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per rep - (b)(6)2025 - the catheter separated from the handle during the procedure.They were able to pull the full system out.Everything was intact.The procedure was successfully completed with another device of the same type.Details of access sheath used (name, fr size, length)? 7 fr, 90cm.What was the target location for the stent? brain.What disease pathology was being treated? stenosis in brain.Was the device used percutaneously? n/a, yes, no? yes.Was pre-dilation performed ahead of placement of the stent? n/a, yes, no? no.What was the access site chosen? right groin.Details of the wire guide used (name, diameter, hydrophilic)? 018 boston scientific v18, not hydrophilic.Was a stent previously placed during previous procedures? no.Did the patient exhibit difficult anatomy (n/a, tortuous, altered, calcified, fibriotic)? (if altered please indicate the procedure type) moderately tortuous.Was the approach ipsilateral or contralateral? n/a, ispilateral, contralateral (if contralateral, was the bifurcation angle steep? n/a, yes, no) ipsilateral.What intervention (if any) was required? none.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 -n/a.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G., kink)? n/a, yes, no (if yes, please specify what additional defect(s) were observed and where on the device this was observed) no.What was the position of the elevator during deployment? -rep does not understand question.Was there resistance felt passing the delivery system through the stricture? yes, normal for brain.Was the stent being placed through the side wall of a previously placed stent? no.Did any part of the product snag/get caught on the stent when removing the delivery system? no.
Additional Manufacturer Narrative
G4 - pma/510(k) # p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
G4 - pma/510(k) # p050017/s002 and s003.Device evaluation: 1 unit of lot c2333813 of ziv5-18-125-9-80 was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation on 09 february 2026.Observations from the lab evaluation were as follows; red safety tab not returned.Device returned with outer sheath separated from handle directly below white connector cap.Outer sheath examined and no other issues observed.White distal tip examined and no issues observed.Device flushes without any issue.0.018 inch wire guide passes through device without any issue.Unable to deploy stent due to outer sheath separation noted previously.The reported failure was observed.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 for another zilver vascular complaint (b)(4) deploying zilver vascular stent into ¿venous sinus vein in brain¿ is an off-label/abnormal use.Engineering was contacted to check if the off label/abnormal use of deploying zilver vascular stent into stenosis in the brain would have caused the complaint issue and they confirmed that it is likely that the abnormal use led to the device failure 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 deploying zilver vascular stent into stenosis in the brain is an off label/abnormal use and engineering have confirmed that it is likely that the abnormal use led to the device failure.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 18-feb-26.

• 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: 23986869
• Report Number: 3001845648-2026-00015
• Device Sequence Number: 10704573
• Product Code: NIO
• UDI-Device Identifier: 10827002437880
• UDI-Public: (01)10827002437880(17)280818(10)C2333813
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 02/18/2026

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: G43788
• Device Catalogue Number: ZIV5-18-125-9-80
• Device Lot Number: C2333813
• 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: 12/19/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/16/2026
• 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: 73 YR
• Patient Sex: Female