MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Model Number	G57448
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: nio stent, iliac.Product code: qan.Pma/510(k) #: p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Complaint received from dm via e-mail on (b)(6) 2021--(b)(6) 2021.As reported to customer relations: "a physician was performing a venous intervention and had an issue with the deployment of our zilver vena stent.As he was trying to deploy the stent, the silver handle seemed to have friction and/or got caught on something within the deployment catheter as he was trying to pin/pull.This caused the stent to jump further toward the ivc than the physician would have liked.When he removed the stent from the patient and placed it on the table, he was still able to replicate the issue and the handle was getting caught on something when pushing it in and out of the system.Device- g57448.Lot- c1770415.Access site- left common femoral vein.Deployment site- left common iliac vein.Due to this deployment issue, physician felt it was necessary to place another kissing iliac stent on the right side.They will not be reporting to fda." if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? yes, a bilateral stent on other side.If yes, please describe.Did the product cause or contribute to the need for additional procedures? yes, bilateral stent placed on other side.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? none yet.Has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Are images of the device or procedure available? yes, will send the device back, though.Additional information provided by dm on 21jun2021: "does this mean that imagery will be provided? we do not have imagery to provide at this time.I apologize." (b)(6) 2021.Did the patient have pre-existing conditions? n/a, yes, no.If yes, please specify: please describe the native state of the vessel (i.E.Was the anatomy tortuous? venous compression.Was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other, if other, please specify: was a stent previously placed during previous procedures? no.Was the device used percutaneously? yes.Where on the patient was the percutaneous access site? was the access site jugular or femoral? n/a, jugular, femoral other if other, please specify: what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify) may thurner compression.Was the lesion approached via contralateral or ipsilateral? ipsilateral.Was pre-dilation performed ahead of placement of the stent? no.What was the target location for the stent? details of access sheath used (name, fr size, length)? 10fr sheath, unsure of name was the device flushed through both flushing ports before the procedure, as per ifu? yes.Details of the wire guide used (name, diameter, hyrdophyllic)? unsure of wire.Was resistance encountered when advancing the wire guide to the target location? not with wire.Was resistance encountered when advancing the delivery system to the target location? yes.If resistance was met, how did the physician address this? he used more force to pin/pull device.Did the tip of the delivery system cross the target location? yes.Did the user pull the handle towards the hub during deployment, per ifu? yes.Did the user push the hub during deployment? physician says no.Did the user remove slack in the delivery system before deployment, per ifu? yes.Was the stent deployed smoothly / without resistance? n/a, yes, no.Was the stent fully deployed in the patient? yes.Was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no.Was post dilation performed after the placement of the stent? yes.Was the delivery system damaged/kinked/twisted during deployment? do not believe so.What intervention (if any) was required? additional stent.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? another day same day.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no.Please specify if yes.No.
Additional Manufacturer Narrative
D2) nio stent, iliac.D2b) product code: qan.Pma/510(k) #: p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report required: device evaluated on 28-jun-21: "outer sheath kinked".
Additional Manufacturer Narrative
Common name - qan.Product code - qan.Pma/510(k) # p200023.Device evaluation: the zvt7-35-80-16-100 device of lot number c1770415 involved in this complaint was returned for evaluation, without original packaging.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 june 2021.On evaluation of the device a kink was observed approx.0.2cm from distal end of the white connector cap on the outer sheath.The device flushed as expected.A 0.035 inch wire guide could not pass the kink on the outer sheath.Document review prior to distribution zvt7-35-80-16-100 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 cirl.A review of the manufacturing records for zvt7-35-80-16-100of lot number c1770415 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 c1770415.It should be noted that the instructions for use are ifu0091-7.There is no evidence to suggest the user did not follow the ifu.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.It is known that the patient suffered from may thurner compression.Therefore, a possible root cause could be attributed to difficult patient anatomy.The complaint is confirmed based on customer testimony.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.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• 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: 12047438
• Report Number: 3001845648-2021-00510
• Device Sequence Number: 19669960
• Product Code: QAN
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)231021(10)C1770415
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: G57448
• Device Catalogue Number: ZVT7-35-80-16-100
• Device Lot Number: C1770415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2021
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 05/28/2021; 05/28/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/27/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female