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

Catalog Number	ZISV6-35-125-6-140-PTX
Medical Device Problem Codes	Activation Failure (3270); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # p100022/s026.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Following deployment of the stent, there was a finding of a potential folding or under expanded portion on distal end of stent (stent edge under deployed).Angioplasty with ballooning was performed but was unsuccessful in correcting the under deployment.A bare metal stent was placed to overlap and keep the stent open.
Additional Manufacturer Narrative
Pma/510(k)#: p100022/s026.This file was opened in response to a report from dmac vascular lab, llc that the ¿edge of the stent under deployed¿.Device evaluation: the device evaluation could not be completed as the zisv6-35-125-6-140-ptx device of lot number c2125559 or photographic evidence of the device was not returned for evaluation.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 for lot number c2125559 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: there is no evidence to suggest that the customer did not follow the ifu/label.Ifu0018 image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be established.Multiple attempts to obtain further information were made but further information was not forthcoming.Because of this, only possible root causes can be attributed.If further information becomes available, the file can be reopened and updated.A possible root cause of difficult or tortuous patient anatomy could be attributed.If the patient anatomy was tortuous, this could have caused compression of the stent and prevented it from fully expanding, requiring the second, bare metal stent, to be placed to keep the first stent fully expanded.Another possible root cause could be attributed to the possibility of inadequate pre-dilation before stent placement could be attributed.If the pre-placement dilation wasn¿t adequate, this could have prevented the first stent from fully expanding, requiring the second, bare metal, stent to keep the first stent fully dilated.Pre-dilation before stent placement is optional and at the discretion of the physician.These possible root causes are supported by medical advisor input.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.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.Summary of investigation: this file was opened in response to a report from dmac vascular lab, llc that the ¿edge of the stent under deployed¿.Confirmed quantity of 01 device used.According to the initial reporter the patient required angioplasty with ballooning, and a bare metal additional stent to be placed during the same procedure.Possible root causes of difficult or tortuous patient anatomy and/or inadequate pre-dilation were determined.Due to lack of information, these are only possible root causes, should further information become available, the file can be reopened and updated.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 29-aug-2024.

• 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; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18929066
• Report Number: 3001845648-2024-00097
• Device Sequence Number: 11890573
• Product Code: NIU
• UDI-Device Identifier: 10827002384832
• UDI-Public: (01)10827002384832(17)251114(10)C2125559
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100022
• 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): 08/29/2024

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 Expiration Date: 11/14/2025
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C2125559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2023
• 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