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

Model Number	G43773
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As initially reported to customer relations: a female patient of undisclosed age underwent a left leg pta and stent placement procedure in which the zilver 518 vascular self-expanding stent, g43773, was used.The physician gained access via the right groin and went contralateral to the left leg.While attempting to deploy and place stent the flexor material came off of the handle.The device was removed from the patient, no stent was deployed, and opened another of the same device to complete the procedure.Patient outcome: 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.Patient/event info - notes: 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)? 5fr x 4cm ansel sheath.What was the target location for the stent? not specified by end user.Was the product inspected for kinks or damage before use? yes.Was the device used percutaneously? yes.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? n/a- stent not implanted.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? not specified by end user.Was resistance encountered when advancing the delivery system to the target location? no.How did the physician deal with this resistance? n/a.Was the approach ipsilateral or contralateral? contralateral.If contralateral, was the bifurcation angle steep? normal bifurcation.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- normal bifurcation.Was the delivery system damaged/kinked/twisted during deployment? no.Was the handle pulled towards the hub during deployment? yes.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: see event description.What artery was the stent placed in? n/a- -stent was not deployed- see event description.Was the stent fully deployed from the delivery system prior to removal of the delivery system? n/a- see event description.Did the patient have any pre-existing conditions? not specified by end user.If yes, please specify: did the patient require any additional procedures as a result of this event? no- see patient outcome questions.What intervention (if any) was required? no- see patient outcome questions.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a- see event description/patient outcome.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.Per manufacture request the following questions were sent to the district manager on & response received on 22mar2023.Email is attached.What size wire guide was used e.G.0.018", 0.025",0.035"? 014.What were the patients pre-existing conditions? n/a.What was the target location for the device? sfa.Was there any difficulty/resistance experienced while advancing the wire guide? no th 22mar2023.Per cook ireland-- a request for the following information was sent to the district manager who replied via phone conversation on 07apr2023.If the 0.014 inch wire was also on the replacement device? information was not provided by end user.The rpn and lot number of the replacement device used? information was not provided by end user.Th 07apr2023.Lab evaluation complete on 04th april 2023.
Additional Manufacturer Narrative
Pma/510(k) # p050017/s002 and s003.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # p050017/s002 and s003.Device evaluation: off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Trending will monitor if any future investigation is required.The ziv5-18-125-6-80 device of lot number c1985617, involved in this complaint, were returned for evaluation without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Pr 393864 was raised to capture the off label use of the successful replacement device used to complete the procedure.The device related to this occurrence underwent a laboratory evaluation on the 04th april 2023.On evaluation of the device, the following was observed: visual inspection: ¿ red safety tab not returned.¿ outer sheath separated from the handle functional inspection: ¿ 0.018" wire guide passed with no issue.This is the required wire guide for this device.¿ device flushed with no issue.¿ unable to deploy stent.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 did not reveal any discrepancies that could have contributed to this complaint issue ifu/label review: there is evidence to suggest that the customer did not follow the instructions for use.It should be noted that the instructions for use (ifu0043) 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.¿ from the information given, it is known that the physician attempted to deploy the stent in the sfa for which they are not intended.It is also known that the user used an incorrect wire guide during this procedure.It is known that the user used a 0.014 inch wire guide where the required size is a 0.18inch wire guide.As per ifu0043 states ¿5.0 french (1.67mm) system accepts 0.018 inch(0.46mm) wire guide¿.Image review an image was not returned for evaluation root cause review a definitive root cause of off label use was determined from the investigation.From the information available, it is known that the physician attempted to deploy this stent in the sfa for which they are not intended.Using a device outside its validated intended area of use, means we cannot predict how the device will perform.Using this device in the sfa may have caused the delivery system to separate from the handle as the sfa is not the intended location of these devices.As per d00213689, rev006, off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Also secondary to the off label use, it is known that the user used an incorrect wire guide during this procedure.It is known that the user used a 0.014 inch wire guide where the required size is a 0.18inch wire guide.This smaller wire guide may have not provided sufficient support during advancement/deployment, creating a need for greater force to be used and thus leading to the flexor separation at the handle.Both the off label use and the user error of the non required wire guide used, could have both contributed/caused the flexor material to come off the handle.Confirmation of complaint: complaint is confirmed as the failure was verified in the laboratory summary: according to the initial reporter a female patient of undisclosed age underwent a left leg pta and stent placement procedure in which the zilver 518 vascular self-expanding stent, g43773, was used.The physician gained access via the right groin and went contralateral to the left leg.While attempting to deploy and place stent the flexor material came off of the handle.The device was removed from the patient, no stent was deployed, and opened another of the same device to complete the procedure.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.A second device was used to successfully complete the procedure.Investigation findings conclude that a definitive root cause was established.The user has not complied with the requirements of the ifu with respect to the intended use of the device.From the information given, it is known that the physician attempted to deploy this stent in the sfa for which they are not intended.The ifu states that ¿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".Also secondary to the off label use, it is known that the user used an incorrect wire guide during this procedure.It is known that the user used a 0.014 inch wire guide where the required size as stated in the ifu is a 0.18inch wire guide.Both the off label use and the user error of the non required wire guide used, could have both contributed/caused the flexor material to come off the handle complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on the 25-may-2023.

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16775221
• Report Number: 3001845648-2023-00248
• Device Sequence Number: 6820848
• Product Code: NIO
• UDI-Device Identifier: 10827002437736
• UDI-Public: (01)10827002437736(17)251011(10)C1985617
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 10/11/2025
• Device Model Number: G43773
• Device Catalogue Number: ZIV5-18-125-6-80
• Device Lot Number: C1985617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2023
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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: Female