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

Model Number	G38482
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
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
Per the complaint email from the field representative: "the 6 by 120 ptx that was in a 6fr 45cm ansel sheath up and over that where the first and second physicians at the medical center went to fully deploy after the first physician doing the thumb wheel completely, about 1cm was completely still not deployed and stuck.The second physician made a phone call to me to see what options we had.By the time we discussed, the first physician was able to get the end of it out as he pulled it back.But they said it was strange as it wasn't fully expanded.They saved deployment device." patient was fine.
Additional Manufacturer Narrative
Device evaluation: 1 unit of lot number c2256335 of zisv6-35-125-6-120-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.Visual inspection: red safety button returned pressed.Crinkling noted along delivery system approx.33cms to 39cms from the white distal tip.No other damage noted.Biological material noted in delivery system functional inspection: unable to flush device.0.035 inch wire guide unable to be passed through device beyond biological material previously noted.Approx.6cms of wire guide would pass through.Stent not returned - deployed by user as per complaint report.The device involved in the complaint was re-evaluated in the laboratory on 01 jul 2025 visual inspection: crinkling noted along delivery system approx.33cms to 39cms from the white distal tip.Functional inspection: flushed device and significant biological matter present.Approx.61cm of wireguide passed through, cut across the delivery system distal to the strain relief, stability sheath separated from retraction sheath and no issues observed, blockage in inner catheter, wire guide would not fully advance through it.Manufacturing records: prior to distribution, all zisv6-35-125-6-120-ptx devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for zisv6-35-125-6-120-ptx device of lot number c2256335 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: a review of the manufacturing records for the zisv6-35-125-6-120-ptx device confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2256335.Instructions for use and label: the precautions section of the instructions for use (ifu0118), which accompanies this device instructs the user "if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device.Continuing to force passage may ultimately cause partial deployment of the stent".There is no 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 not be determined from the available information.Engineering input stated that the device was tracked over the wireguide to the lesion during the attempt to deploy it but something prevented the remaining 1cm from deploying and this was not apparent after evaluating the device.It is possible that the resistance encountered during tracking led to the crinkling observed on the delivery system, which may have been due to a tight anatomy in trying to cross the aortic bifurcation for a contralateral approach which then caused strain during deployment.Several requests were made for additional information but his was not forthcoming, if it is received at a later date then the investigation will be updated accordingly.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 user went to deploy the stent after rotating the thumb wheel but 1cm of the stent did not deploy and remained stuck.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a definitive root cause could not be determined from the available information.Engineering input stated that the device was tracked over the wireguide to the lesion during the attempt to deploy it but something prevented the remaining 1cm from deploying and this was not apparent after evaluating the device.It is possible that the resistance encountered during tracking led to the crinkling observed on the delivery system, which may have been due to a tight anatomy in trying to cross the aortic bifurcation for a contralateral approach which then caused strain during deployment.Several requests were made for additional information but his was not forthcoming, if it is received at a later date then the investigation will be updated accordingly.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 7 jul 2025.

• 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 road; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 21967054
• Report Number: 3001845648-2025-00222
• Device Sequence Number: 15557203
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)261202(10)C2256335
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100022/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/07/2025

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: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: C2256335
• 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: 04/15/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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