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

Model Number	G43782
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	06/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported to customer relations via phone conversation "the flexor part detached from the handle therefore the stent was undeployable." did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no did the patient require any additional procedures due to this occurrence? no if yes, please describe.Did the product cause or contribute to the need for additional procedures? no if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? no has the complainant reported that the product caused or contributed to the adverse effects? no please specify adverse effects and provide details.Ziv5/ziv6/zfv6 are images of the device or procedure available? no at what stage of the procedure did the complaint occur? stent placement details of access sheath used (name, fr size, length)? cook 545 what was the target location for the stent? sfa was the product inspected for kinks or damage before use? n/a was the device used percutaneously? no was the device flushed through both flushing port before the procedure, as per ifu? yes was pre-dilation performed ahead of placement of the stent? yes was post-dilation performed after the placement of the stent? no, stent was not deployed details of the wire guide used (name, diameter, hyrdophyllic)? hydro st did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? no was resistance encountered when advancing the wire guide to the target location? no was resistance encountered when advancing the delivery system to the target location? no how did the physician deal with this resistance? n/a did not encounter resistance was the approach ipsilateral or contralateral? contralateral ¿ if contralateral, was the bifurcation angle steep? no did the tip of the delivery system cross the target location? yes was the delivery system tracked around a tight angle in the patient anatomy? no was the delivery system damaged/kinked/twisted during deployment? damaged but not the part that was in the patient was the handle pulled towards the hub during deployment? no was the delivery system pushed during deployment? no was the stent deployed smoothly / without resistance? n/a- stent was not deployed ¿ if no, please detail any difficulty experienced during deployment: what artery was the stent placed in? n/a stent was not placed as it was not deployed was the stent fully deployed from the delivery system prior to removal of the delivery system? n/a did the patient have any pre-existing conditions? none made aware to rep ¿ if yes, please specify: did the patient require any additional procedures as a result of this event? no 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 no secondary required were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no ¿ please specify if yes.
Additional Manufacturer Narrative
Pma/510(k) # p050017/s002 and s003.Two devices have been returned by the entity.The ziv5-18-125-8-60 device of lot number c1787927 involved in this complaint was returned for evaluation, with the original packaging.A second unused and unopened ziv5-18-125-8-60 device of lot number c1787927 was returned by the customer in the same shipment.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 28th july 2021.On evaluation of the device, separation of the outer sheath from the handle was observed at the distal end of handle, just below the white cap.The device flushed as expected.A 0.018 inch wire guide passed through the device as expected.The stent is contained within the outer sheath but could not be deployed in the lab due to outer sheath separation.Document review prior to distribution ziv5-18-125-8-60 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cook (b)(4).A review of the manufacturing records for ziv5-18-125-8-60 of lot number c1787927 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 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 c1787927.It should be noted that the instructions for use (ifu0043-9) states the following: ¿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¿.There is evidence to suggest the user did not follow the ifu.A definitive root cause of off- label use was identified from the available information.The user used this device for the treatment of a lesion on the sfa.This is considered off label use.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER 518 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12834736
• Report Number: 3001845648-2021-00808
• Device Sequence Number: 17380858
• Product Code: NIO
• UDI-Device Identifier: 10827002437828
• UDI-Public: (01)10827002437828(17)240105(10)C1787927
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 10/22/2021

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: 01/05/2024
• Device Model Number: G43782
• Device Catalogue Number: ZIV5-18-125-8-60
• Device Lot Number: C1787927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/11/2021
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• 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: Male