MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; STENT, ILIAC VEIN

Catalog Number ZVT7-35-80-14-6.0

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p200023.Common name: qan.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

When the stent was released at the lesion site iliac vein, the end of the stent could not be released.After many attempts, the stent could not be released successfully, so the stent was pulled out of the patient and found to be partially released (without protective sheath).Subsequently, another rpn (zvt7-35-80-16-14.0) was changed to complete the procedure.Cordis 8f arterial sheath used.Complaint opened to capture the use of a non-recommended size access sheath.Related to pr: (b)(4).Mdr ref#: 3001845648-2023-00071- a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information provide-(b)(6), 2023.Are images of the device or procedure available? no.2.Did the patient have pre-existing conditions? no.3.If yes, please specify : 4.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) no.Tortuous? no.Calcified, no.Fibrotic: 5.If other, please specify: 6.Was a stent previously placed during previous procedures? no.7.Was the device used percutaneously? yes 8.Where on the patient was the percutaneous access site? femoral vein 9.Was the access site jugular or femoral? femoral.If other, please specify: 10.What disease pathology was being treated? iliac vein stenosis if other, please specify 11.Was the lesion approached via contralateral or ipsilateral? ipsilateral.12.Was pre-dilation performed ahead of placement of the stent? yes.13.What was the target location for the stent? common iliac vein 14.Details of access sheath used (name, fr size, length)? cordis 8f arterial sheath, 19cm 15.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.16.Details of the wire guide used (name, diameter, hydrophilic ? terumo¿s loach wire guide 17.Was resistance encountered when advancing the wire guide to the target location? no 18.Was resistance encountered when advancing the delivery system to the target location? no 19.If resistance was met, how did the physician address this? 20.Did the tip of the delivery system cross the target location? yes 21.Did the user pull the handle towards the hub during deployment, per ifu? yes 22.Did the user push the hub during deployment? no 23.Did the user remove slack in the delivery system before deployment, per ifu? yes 24.Was the stent deployed smoothly / without resistance? no 25.Was the stent fully deployed in the patient? no 26.Was the stent fully deployed before removing the delivery system from the patient? no 27.Was post dilation performed after the placement of the stent? no 28.Was the delivery system damaged/kinked/twisted during deployment? no 29.Did the patient require any additional procedures as a result of this event? no 30.What intervention (if any) was required? no 31.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 32.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no 33.Please specify if yes.

Manufacturer Narrative

Pma/510(k) #: p200023.Device evaluation the zvt7-35-80-14-6.0 device of lot number c1854025 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.This file was raised as an additional complaint to capture the user error of using an incorrect size access sheath from complaint (b)(4) (mdr ref.3001845648-2023-00071).Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 31st january 2023.On evaluation of the device the following was noted: visual inspection: stent returned separately and intact.Function inspection: device flushed with no issue.0.035¿ wire guide passed 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 the relevant manufacturing records confirms the failure mode has not previously occurred for this work order.It should be noted that the instructions for use states the following: ¿for venous access, the use of an access set that accepts a 7.0 french (2.3mm) introducer catheter is recommended¿.There is evidence to suggest that the customer did not follow the instructions for use or label.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause of the user not reading or following the instructions for use has been determined.From the additional questions it is known that an access sheath that accepts an 8fr introducer catheter was used with the device.As previously noted, the ifu states ¿for venous access, the use of an access set that accepts a 7.0 french (2.3mm) introducer catheter is recommended¿.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation on 30-mar-2023 and an update to the investigation conclusions.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: 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: 16551824
• MDR Text Key: 311401683
• Report Number: 3001845648-2023-00174
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002520223
• UDI-Public: (01)10827002520223(17)240729(10)C1854025
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVT7-35-80-14-6.0
• Device Lot Number: C1854025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/28/2022
• Event Location: Hospital
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG