MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	G38489
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The zilver ptx stent (info attached) wasn't successfully deployed.The physician was wanting to deploy it in the proximal sfa which was super calcified, but the stent wouldn't pass through the sheath on the contralateral side.When he removed the stent to examine it, the delivery catheter was kinked.The patient wasn't harmed, and the stent was successfully removed before it was deployed.Another stent (same size and same lot number) was successfully placed with no issue.Additional info received 03-apr-2025.1.Was the device flushed before the procedure, as per ifu? n/a, yes, no.-yes it was flushed it was flushed.2.Were there any issues with flushing of the device? n/a, yes, no.-no issues flushing.3.Details of the access sheath used (name, fr size, length)? -terumo 6 french sheath up and over.4.Details of the wire guide used (name, diameter, hydrophylic)? -.014 glide advantage.5.Was the wire guide removed from the patient prior to advancing the delivery system? n/a, yes, no.-no, not removed.6.If removed, was the wire guide wiped prior to advancement of the delivery system? n/a, yes, no, -the wire was in place.7.Was pre-dilation performed ahead of placement of the stent? n/a,yes,no.-yes, predilated.8.Was resistance encountered when advancing the wire guide? n/a, yes, no.-no.9.Was resistance encountered when advancing the delivery system to the target location? n/a, yes, no.-yes.10.How did the physician deal with any resistance encountered?.-looked under fluoro and saw the delivery catheter was kinked.11.Thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? n/a, yes, no.-no it was distal access to the sheath.12.Thumbwheel only ¿ was the retraction sheet being held during deployment.N/a, yes, no.-no because it wasn't deployed.13.Did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? n/a, yes, no.-not deployed.
Additional Manufacturer Narrative
Device evaluation: (b)(4) unit of lot number c2251827 of zisv6-35-125-7-100-ptx was returned opened not in its original packaging.With the information provided, a physical examination and document-based investigation was conducted.The device involved in the complaint was evaluated in the laboratory on 13 may 2025.The returned device lab findings and observations can be referred through the attached files.Visual inspection: red safety button returned intact.Kink noted approx.23cms on delivery system from white distal tip.Functional inspection: device flushed with no issue.Biological matter emitted during flushing.0.035-inch wire guide unable to pass beyond kink seen at approx.23cms as noted above.Red safety button depressed.Stent began to deploy with resistance while rotating thumbwheel however, the outer sheath stopped retracting even though the thumbwheel was still turning.Stent unable to be fully deployed.Manufacturing records: prior to distribution, all zisv6-35-125-7-100-ptx devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for zisv6-35-125-7-100-ptx device of lot number c2251827 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and label: the precautions section of the instructions for use (ifu0118), which accompanies this device instructs the user "a 0.035-inch (0.89mm) diameter wire guide should be used during tracking, deployment, and removal in order to ensure adequate support of the system" there is evidence to suggest that the customer did not follow the instructions for use.(ifu0118).Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could be attributed to use error.It may be noted the device label indicates a 0.035¿ wire guide for use with this device and all simulated use testing to date has been completed using a 0.035¿ wire guide.As per information provided a 0.14" wireguide was used.The reported issue of the stent being kinked and the delivery system being kinked consequently making it impossible to deploy would have been a cascading effect of the 0.14" wireguide being used.Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Confirmation of complaint: complaint is confirmed based on visual/functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer, the stent was unable to be fully deployed and was found to be kinked.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not suffer any adverse effects.Investigation findings conclude that a definitive root cause could be attributed to use error.It may be noted the device label indicates a 0.035¿ wire guide for use with this device and all simulated use testing to date has been completed using a 0.035¿ wire guide.As per information provided a 0.14" wireguide was used.The reported issue of the stent being kinked and the delivery system being kinked consequently making it impossible to deploy would have been a cascading effect of the 0.14" wireguide being used.Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 26-jun-25.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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: 21885524
• Report Number: 3001845648-2025-00209
• Device Sequence Number: 8190141
• Product Code: NIU
• UDI-Device Identifier: 10827002384894
• UDI-Public: (01)10827002384894(17)261121(10)C2251827
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100022/S014
• 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): 06/26/2025

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: G38489
• Device Catalogue Number: ZISV6-35-125-7-100-PTX
• Device Lot Number: C2251827
• 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: 03/26/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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