MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; Stent, iliac vein

Model Number	G57443
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Structural Problem (2506); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma # p200023 / common name - qan.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
"occurred in ir; did not occur in cardiac cath lab.As the zilver vena was attempted to be deployed, the inari sheath gripped on the outer shaft of the stent, and caused the separation of the outer sheath.Did not cause total separation of the device (still in 1 piece).User was able to safely remove form the patient.No patient injury.Proceeded by deploying a different zilver device (as they didn't have the same gpn available).User determined that they needed to push the 2 grey buttons on the inari introducer sheath to allow for passage of the zilver stent.Inari rep, also present, said they'd never seen that happen either.1.Did any unintended section of the device remain inside the patient¿s body? no ¿ if yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.¿ if yes, please describe.3.Did the patient require any additional procedures due to this occurrence? no ¿ if yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no ¿ if yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no.6.Has the complainant reported that the product caused or contributed to the adverse effects? no.¿ please specify adverse effects and provide details.Prefix zvt7 3.94 are images of the device or procedure available? n/a,yes,no no.3.95 did the patient have pre-existing conditions? n/a, yes, no asku.¿ if yes, please specify: 3.96 please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other; thrombotic but unrelated ¿ if other, please specify: 3.97 was a stent previously placed during previous procedures? n/a, yes, no; no.3.98 was the device used percutaneously? n/a,yes,no; yes.3.99 where on the patient was the percutaneous access site? popliteal 3.100 was the access site jugular or femoral? n/a, jugular, femoral other ¿ if other, please specify:; n/a 3.101 what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? may thurner ¿ if other, please specify 3.102 was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral; ipsilateral 3.103 was pre-dilation performed ahead of placement of the stent? n/a, yes, no; yes 3.104 what was the target location for the stent? common iliac vein, external iliac vein 3.105 details of access sheath used (name, fr size, length)? inari, 14 or 16 french 3.106 was the device flushed through both flushing ports before the procedure, as per ifu? n/a,yes,no; yes 3.107 details of the wire guide used (name, diameter, hydrophylic)? amplatz extra support.035 3.108 was resistance encountered when advancing the wire guide to the target location? n/a, yes, no; no 3.109 was resistance encountered when advancing the delivery system to the target location? n/a, yes, no; no 3.110 if resistance was met, how did the physician address this? n/a 3.111 did the tip of the delivery system cross the target location? n/a,yes,no; yes 3.112 did the user pull the handle towards the hub during deployment, per ifu? n/a,yes,no; yes 3.113 did the user push the hub during deployment? n/a, yes, no; no 3.114 did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no; yes 3.115 was the stent deployed smoothly / without resistance? n/a, yes, no; no 3.116 was the stent fully deployed in the patient? n/a, yes, no; no 3.117 was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no; no 3.118 was post dilation performed after the placement of the stent? n/a, yes, no; n/a wasn't deployed 3.119 was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no; cut in half (circumferentially detached) from proximal 3.120 what intervention (if any) was required? no 3.121 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day; no 3.122 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no; no ¿ please specify if yes.
Additional Manufacturer Narrative
P200023 - pma # qan - common name.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report being submitted due to completion of lab evaluation on (b)(6) 2021.Lab eval completed on (b)(6) 2021: *outer sheath separated.*stent partially deployed.
Event or Problem Description
Supplemental report being submitted due to confirmation of user error on 26-may-2022.As per ifu00091, ¿hold the hub on the metal cannula steady.To initiate deployment of the stent, remove the red safety lock".A per the complaint description: ¿inari sheath gripped on the outer shaft of the stent, and caused the separation of the outer sheath.¿ annex a and g codes updated.
Additional Manufacturer Narrative
P200023 - pma #; qan - common name.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
P200023 - pma # qan - common name device evaluation the zvt7-35-120-12-140 device of lot number c1771380 involved in this complaint was returned for evaluation, without original packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 5th november 2021.On evaluation of the device it was observed that the outer sheath separated between approx.21cm and 25 cm on the outer sheath from the white connector cap.The stent was observed partially deployed approx.4mm from the distal end of the outer sheath.The device flushed as expected.A 0.035 inch wire guide passed through the device without issue.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 for zvt7-35-120-12-140 of lot number c1771380 did not reveal any discrepancies that could have contributed to this complaint issue.An nc code (gen-111) was noted on the work order however these units were subsequently scrapped and would not have attributed to this complaint issue.Review historical data the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/or label there is no evidence to suggest that the customer did not follow the instructions for use (ifu0091).Image review an image was not returned for evaluation root cause analysis no root cause determination is required as the complaint is not confirmed.The issue of the outer sheath separating does not lie with the cook device.The issue occurred as the inari introducer sheath clamped on the outer sheath of the cook device, gripping on it and causing the separation as the attempted deployment began.The user then determined that they needed to push 2 grey buttons on the inari introducer sheath to allow for passage of the zilver stent which they did on the replacement device that was used successfully.The ifu that accompanies the cook zilver vena device does not give any instructions regarding the use of the inari introducer sheath or contain any information regarding the need to push the grey buttons on the introducer sheath that is used, when attempting the deployment of the cook stent.Confirmation of complaint the complaint cannot be confirmed because the device or the procedure have not caused or contributed to the events reported.Summary of investigation according to the initial reporter, as the zilver vena was attempted to be deployed, the inari sheath gripped on the outer shaft of the stent and caused the separation of the outer sheath.It did not cause total separation of the device (still in 1 piece) and the user was able to safely remove from the patient.They determined that they needed to push 2 grey buttons on the inari introducer sheath to allow for passage of the zilver stent.They proceeded by deploying a different zilver device.Unconfirmed quantity of 01 device as complaint is not confirmed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The initial device was removed from the patient safely.Once they determined that the 2 grey buttons on the inari sheath needed to be pushed, they deployed another stent successfully.Investigation findings conclude that this complaint is not confirmed.This issue occurred due to the incorrect usage of an inari introducer sheath and the issue did not lie with the cook device.The complaint cannot be confirmed because the device or the procedure have not caused or contributed to the events reported.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This report is being submitted due to the completion of the investigation on the 06/20/2023.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Common Device Name: Stent, iliac vein
• 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: 12606076
• Report Number: 3001845648-2021-00719
• Device Sequence Number: 1231774
• Product Code: QAN
• UDI-Device Identifier: 10827002574431
• UDI-Public: (01)10827002574431(17)231029(10)C1771380
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/20/2023

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: 10/29/2023
• Device Model Number: G57443
• Device Catalogue Number: ZVT7-35-120-12-140
• Device Lot Number: C1771380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2021
• Device Age: 319 YR
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 09/14/2021; 09/14/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 12/03/2021; 06/24/2022; 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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
• Patient Sex: Unknown