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

Model Number G57455

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 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As per (b)(4) a 8fr terumo short sheath (11 cm).As per ifu0091, an access sheath that accepts a 7fr introducer catheter is recommended.This file will capture the user error of the incorrect size access sheath.Patient/event info - notes: the following information has been requested via email on 20apr2023.(b)(6) 2023.Are images available? was the migrated stent removed? was a new stent put in? please provide the originator a list of any additional manufacturer questions required for investigation.(b)(6) 2023 the following information has been received via email on 20apr2023.(b)(6) 2023.Was the migrated stent removed? yes.Was a new stent put in? no.The following information has been requested via email on 09may2023.(b)(6) 2023.1.Are images of the device or procedure available? 2.Did the patient have pre-existing conditions? a.If yes, please specify : 3.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other a.If other, please specify: 4.Was a stent previously placed during previous procedures? 5.Was the device used percutaneously? 8.Where on the patient was the percutaneous access site? 6.Was the access site jugular or femoral? n/a, jugular, femoral other a.If other, please specify: 7.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify 8.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral 9.Was pre-dilation performed ahead of placement of the stent? 10.What was the target location for the stent? 11.Details of access sheath used (name, fr size, length)? 12.Was the device flushed through both flushing ports before the procedure, as per ifu? 16.Details of the wire guide used (name, diameter, hyrdophyllic)? 13.Was resistance encountered when advancing the wire guide to the target location? 14.Was resistance encountered when advancing the delivery system to the target location? a.If resistance was met, how did the physician address this? 15.Did the tip of the delivery system cross the target location? 16.Did the user pull the handle towards the hub during deployment, per ifu? 17.Did the user push the hub during deployment? 18.Did the user remove slack in the delivery system before deployment, per ifu? 19.Was the stent deployed smoothly / without resistance? 20.Was the stent fully deployed in the patient? 21.Was the stent fully deployed before removing the delivery system from the patient? 22.Was post dilation performed after the placement of the stent? 23.Was the delivery system damaged/kinked/twisted during deployment? 24.Did the patient require any additional procedures as a result of this event? 25.What intervention (if any) was required? 26.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 27.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? a.Please specify if yes.The following information has been received via email on 14may2023.(b)(6) 2023.1.Are images of the device or procedure available? a.Yes- you should have the device as well.2.Did the patient have pre-existing conditions? a.If yes, please specify : no.3.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.A.If other, please specify: minimal tortuosity, no calcification, no fibrotic material.4.Was a stent previously placed during previous procedures? a.Yes during venogram with ivus for compression.5.Was the device used percutaneously? 8.Where on the patient was the percutaneous access site? a.Yes, left femoral vein.6.Was the access site jugular or femoral? n/a, jugular, femoral other a.If other, please specify: 7.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify a.May-thurner with c4 disease.8.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral a.Ipsilateral.9.Was pre-dilation performed ahead of placement of the stent? a.No.10.What was the target location for the stent? a.Common iliac vein.11.Details of access sheath used (name, fr size, length)? a.8fr terumo short sheath (11 cm).12.Was the device flushed through both flushing ports before the procedure, as per ifu? 16.Details of the wire guide used (name, diameter, hyrdophyllic)? a.Yes, wire used was 7 cm tip amplatz wire.13.Was resistance encountered when advancing the wire guide to the target location? a.No.14.Was resistance encountered when advancing the delivery system to the target location? no.A.If resistance was met, how did the physician address this? 15.Did the tip of the delivery system cross the target location? yes 16.Did the user pull the handle towards the hub during deployment, per ifu? a.Yes.17.Did the user push the hub during deployment? no.18.Did the user remove slack in the delivery system before deployment, per ifu? yes.19.Was the stent deployed smoothly / without resistance? yes.20.Was the stent fully deployed in the patient? yes.21.Was the stent fully deployed before removing the delivery system from the patient? yes.22.Was post dilation performed after the placement of the stent? yes.23.Was the delivery system damaged/kinked/twisted during deployment? no.24.Did the patient require any additional procedures as a result of this event? yes.Attempted removal endo but had some endothelial ingrowth and required open removal from the right atrium/ventricle.25.What intervention (if any) was required? see above.26.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.6 months later.27.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.A.Please specify if yes.

Manufacturer Narrative

Pma/510(k) #p200023.Device evaluation user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.The zvt7-35-120-16-140 device of lot number c1846478 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 complaint is related to (b)(4) / mdr ref# 3001845648-2023-00339 and was raised to capture the user error of an incorrect size access sheath used during the initial procedure.The device related to this occurrence underwent a laboratory evaluation on the 25th may 2023.On evaluation of the device the following was noted: visual inspection: stent returned in two pieces with multiple fractures observed on both functional inspection ¿ n/a 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 did not reveal any discrepancies that could have contributed 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 it should be noted that the instructions for use (ifu0091) states the following: ¿gain access at the appropriate site utilizing a 2.3mm (7.0 french) introducer sheath¿.There is evidence to suggest that the customer did not follow the instructions for use image review an image was not returned for evaluation.Root cause analysis 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 8fr terumo access sheath was used with the device.As previously noted, the ifu states ¿gain access at the appropriate site utilizing a 2.3mm (7.0 french) introducer sheath¿.Confirmation of complaint is confirmed based on customer and/or rep testimony summary of investigation according to the additional information received, it is known that an 8fr terumo access sheath was used with the device.The ifu instructs to use a 7fr access sheath.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.Investigation findings conclude a definitive root cause of use error was established.The user has not complied with the requirements of the ifu.From the information available, it is known that an 8fr terumo access sheath was used with the device and not the intended 7fr size as required as per the ifu.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 29-aug-2023.

• 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: 17105166
• MDR Text Key: 317953737
• Report Number: 3001845648-2023-00458
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574554
• UDI-Public: (01)10827002574554(17)240702(10)C1846478
• 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,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57455
• Device Catalogue Number: ZVT7-35-120-16-140
• Device Lot Number: C1846478
• 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: 04/12/2023
• Event Location: Hospital
• Date Manufacturer Received: 05/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2021
• 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