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

Model Number	G38491
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When attempting to deploy the stent the physician started to the thumb wheel rotation with initial retraction of the retraction sheath.Before the stent was exposed the retraction sheath stopped moving even though the physician was continuing to rotate the thumb wheel.The physician decided to remove the deployment system but the system would not go back into the 6fr sheath.The physician removed the whole system and sheath wire.Once the system was removed it was noticed that the white nose cone came detached from the delivery system and left in the popliteal artery.The nose cone was snared and removed from the patient.The procedure was completed with two other g38491/lot #c2001290.7fr x 55cm raabe access sheath used on replacement device.Complaint opened to capture the use of a wrong size access sheath.Related file: pr385391.Patient outcome: no adverse effects.
Additional Manufacturer Narrative
Pma/510(k) # p100022/s026.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # p100022/s026 device evaluation the zisv6-35-125-7-140-ptx device of lot number c2001290 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was raised as an additional complaint to capture the user error of using an incorrect size access sheath on the replacement device from complaint (b)(4) (mdr ref.- 3001845648-2023-00086).Lab evaluation the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Document review 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.The review of the relevant manufacturing records confirms the failure mode has not previously occurred for this work order.It should be noted that the instructions for use states the following: ¿gain access to the site using a 6 french sheath with a minimum i.D.Of 2.0 mm¿.There is evidence to suggest that the customer did not follow the instructions for use or label.As per additional information received, it is known that the user used a 7fr raabe cooke sheath.This is not the required access sheath required for this device.Image review an image was not returned for evaluation root cause review a definitive root cause of the user not reading or following the instructions for use has been determined.From the additional questions it is known that an access sheath that accepts an 7fr introducer catheter was used with the replacement devices.This is not the required access sheath required for this device.As previously noted the instructions for use states the following: ¿gain access to the site using a 6 french sheath with a minimum i.D.Of 2.0 mm¿.The user has not complied with the requirements of the ifu with respect to the intended use of the device.User/use error complaints are considered foreseen misuse.It should be noted that, as the device was used outside of their validated state and/or against the instructions provided in the ifu, it is not possible to predict how the devices will perform or function summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental follow-up mdr correction report is being submitted due to the lab evaluations notes being removed from this file as they are related to the original device captured under pr 385391 (mdr ref.- 3001845648-2023-00086).Supplemental follow-up mdr report also being submitted due to the completion of the investigation on 28-apr-2023 and an update to the investigation conclusions.

• 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: 16688798
• Report Number: 3001845648-2023-00217
• Device Sequence Number: 7346836
• Product Code: NIU
• UDI-Device Identifier: 10827002384917
• UDI-Public: (01)10827002384917(17)241018(10)C2001290
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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: 10/18/2024
• Device Model Number: G38491
• Device Catalogue Number: ZISV6-35-125-7-140-PTX
• Device Lot Number: C2001290
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/16/2023
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2023
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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