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

Model Number G57454

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p200023.Common name - qan.Device evaluation the zvt7-35-120-16-100 device of lot number c1852094 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.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 the user did not follow the ifu.From the information available, it is known that the user did not remove slack from the delivery system before beginning deployment.As per "if excessive resistance is felt when beginning deployment, do not force deployment.Remove the delivery system without deploying the stent and replace with a new device." "ensure the handle remains in a stabilized position while deploying the stent.Tension to remove the slack outside the patients body should be applied, however do not apply excessive tension on the system as stretching of the stent may occur".The user did not follow the steps outlined in the ifu under the stent placement section.Image review: an image was not returned for evaluation.3 attempts were made to ask if images mentioned could be attached or forwarded but were left unanswered.Root cause review a definitive root cause of user error was determined from the available information.From the information available, it is known that the user did not remove slack from the delivery system before beginning deployment and did not follow the steps outlined in the instructions for use.Difficult patient anatomy may also have contributed.From the information given, it is known that patient was being treated for may thurner compression and the vessel was very compressed.Difficult anatomy can cause and/or contribute to resistance during deployment.This may be because the anatomy is compressing the flexor making stent release difficult or because the anatomy was tight around the flexor contributing to resistance as the user attempts to retract the outer sheath.Further questions asked of the physician were left unanswered after 3 attempts.Summary: 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 Description

As reported to customer relations via phone conversation, "upon deployment of the device, the initial unsheathing of the stent was reported to be difficult and more force was needed than requested.It felt like a pop.However, will a bit more force, it deployed." patient outcome: did any unintended section of the device remain inside the patient¿s body? no.Please describe the object and how it was retrieved: did the patient experience a delay or require any additional procedure due to this occurrence? no.Please specify delay or any additional procedure(s) 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: 3.9.Are images of the device or procedure available? yes, 3.92.Did the patient have pre-existing conditions? n/a.If yes, please specify: 3.93, please describe the native state of the vessel (i.E.Was the anatomy tortuous? it was not tortuous, but was heavily compressed was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other no.If other, please specify: 3.94.Was a stent previously placed during previous procedures? no, 3.95.Was the device used percutaneously? yes.3.96.Where on the patient was the percutaneous access site? the groin, common femroal.3.97.Was the access site jugular or femoral? n/a.Jugular, femoral other common femoral.If other, please specify: 3.98.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? may thrurner.If other, please specify: 3.99 was the lesion approached via contralateral or ipsilateral? ipsilateral 3.100 was pre-dilation performed ahead of placement of the stent? yes.3.101.What was the target location for the stent? the common iliac vein.3.102.Details of access sheath used (name, fr size, length)? 9fr access sheath.3.103.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.3.104.Details of the wire guide used (name, diameter, hydrophylic)? 260cm amplatz stiff.3.105.Was resistance encountered when advancing the wire guide to the target location? no.3.106.Was resistance encountered when advancing the delivery system to the target location? no.3.107.If resistance was met, how did the physician address this? n/a.3.108.Did the tip of the delivery system cross the target location? yes.3.109.Did the user pull the handle towards the hub during deployment, per ifu? yes.3.110.Did the user push the hub during deployment? no.3.111.Did the user remove slack in the delivery system before deployment, per ifu? this is where most of the resistance was met.3.112.Was the stent deployed smoothly / without resistance? after the slack was removed, it's yes.3.113 was the stent fully deployed in the patient? yes.114.Was the stent fully deployed before removing the delivery system from the patient? yes.3.115.Was post dilation performed after the placement of the stent? yes.116.Was the delivery system damaged/kinked/twisted during deployment? no.117.What intervention (if any) was required? n/a.3.118.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.3.119.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.

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16443951
• MDR Text Key: 310968509
• Report Number: 3001845648-2023-00131
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574547
• UDI-Public: (01)10827002574547(17)240721(10)C1852094
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2023

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
• Device Operator: Health Professional
• Device Model Number: G57454
• Device Catalogue Number: ZVT7-35-120-16-100
• Device Lot Number: C1852094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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 Sex: Female