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

Model Number	G43783
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # p050017/s002 and s003.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations via phone conversation "the flexor material came detached from the handle x2.Thus, the stent can not be deployed.These were attempted to be used in the same procedure with the same patient.A third g43783-ziv5-18-125-8-80 (different lot number) was opened and used to complete the intended procedure successfully." type of procedure - sfa intervention.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 due to this occurrence? - 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.Are images of the device or procedure available? - no at what stage of the procedure did the complaint occur? unpacking or preparation of the device, insertion, stent placement, removing the introducer.- attempting placement details of access sheath used (name, fr size, length)? - right groin acces (5x45 ansel) what was the target location for the stent? - sfa 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? - the stents were never deployed was post-dilation performed after the placement of the stent? - the stents were never deployed details of the wire guide used (name, diameter, hydrophilic)? - hydro st wire guide did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? - some calcification was resistance encountered when advancing the wire guide to the target location? - yes 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? - n/a 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? - no was the handle pulled towards the hub during deployment? - the physician attempted, but that's when they came apart was the delivery system pushed during deployment? - no 3.52 was the stent deployed smoothly / without resistance? - the stents were not deployed ¿ if no, please detail any difficulty experienced during deployment: - see event description what artery was the stent placed in? - the stents were never placed was the stent fully deployed from the delivery system prior to removal of the delivery system? - no, they would not deploy did the patient have any pre-existing conditions? - n/a if yes, please specify: - n/a did the patient require any additional procedures as a result of this event? - no what intervention (if any) was required? - n/a was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a please specify if yes - n/a.
Event or Problem Description
Supplemental mdr being submitted due to completion of lab evaluation on 25-aug-2022: (b)(4).Used.Visual inspection - red safety tab not returned, the blue other sheath is seperated at the handle.Functional - device flushes without issue.A 0.018inch wire guide passes with no issue.(b)(4).Used.Visual inspection - red safety tab not returned.Blue sheath is seperated at the handle.Functional - device flushes without issue, a 0.018 inch wire guide passes with no issues.(b)(4).Unused.Returned in original packaging.Visual - red safety tab returned in place on device.No damage observed.Functional - device flushes with no issue.0.018inch wire guide passes with no issues.Stent deploys with no issue.(b)(4).Unused.Returned in original packaging.Visual - red safety tab returned in place on device.No damage observed.Functional - device flushes with no issue.0.018inch wire guide passes with no issues.Stent deploys with no issue.
Additional Manufacturer Narrative
Pma/510(k) # p050017/s002 and s003.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 21-oct-22.
Additional Manufacturer Narrative
Pma/510(k) #p050017 s002 and s003.Device evaluation.The 04 devices of rpn ziv5-18-125-8-80 and lot number c1946820, involved in this complaint, were returned for evaluation - 02 used without the original packaging and 02 unused in the original packaging.With the information provided, a physical examination and document-based investigation was conducted.(b)(4) was raised to address the instances of flexor material separating from the handles and (b)(4) was raised for the off label use, of the successful placement of a 3rd device in the sfa.Lab evaluation.The devices related to this occurrence underwent a laboratory evaluation on the 25th august 2022.On evaluation of the devices, the following was observed: (b)(4) returned used.Visual inspection - red safety tab not returned, the blue other sheath is separated at the handle.Functional - device flushes without issue.A 0.018inch wire guide passes with no issue.(b)(4) returned unused in original packaging visual - red safety tab returned in place on device.No damage observed.Functional - device flushes with no issue.0.018inch wire guide passes with no issues.Stent deploys with no issue.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 relevant manufacturing records confirms the failure mode has not previously occurred for this work order.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 deploys these stents in the sfa for which they are not intended.Root cause review a definitive root cause of off label use was determined from the investigation.As per controls, off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.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 which was calcified, may have caused the delivery system to separate from the handle as the sfa is not the intended location of these devices.Summary this pr was raised to address the issue of the outer flexors separating from the handles during use.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.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.A 3rd stent was used and the procedure was completed successfully.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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15248846
• Report Number: 3001845648-2022-00538
• Device Sequence Number: 15088314
• Product Code: NIO
• UDI-Device Identifier: 10827002437835
• UDI-Public: (01)10827002437835(17)250527(10)C1946820
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2022

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: 05/27/2025
• Device Model Number: G43783
• Device Catalogue Number: ZIV5-18-125-8-80
• Device Lot Number: C1946820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/22/2022
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022; 07/25/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/23/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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 Age: 64 YR
• Patient Sex: Male