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

Model Number G57455

Device Problem Migration (4003)

Patient Problem Pancreatitis (4481)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A 16x140 zilver vena stent was placed in the iliac vein in (b)(6) 2022.The patient returned for a duplex ultrasound in (b)(6) 2023 and the stent was seen in the iliac vein.On (b)(6) 2023, the patient went to the emergency room for pancreatitis.The patient was given a ct scan for his pancreatitis.It was incidentally discovered that the zilver stent was no longer in the iliac vein and had migrated to the right ventricle.The following information has been requested via email on 20apr2023.Sg 20apr2023.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.Sg 13apr2023.The following information has been received via email on 20apr2023.Sg 21apr2023.Was the migrated stent removed? yes.Was a new stent put in? no.The following information has been requested via email on 09may2023.Sg 09may2023.1.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.

Event Description

Supplemental report is being submitted due to the completion of lab evaluation on 25-may-2023.

Manufacturer Narrative

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

Manufacturer Narrative

Pma 510k #p200023.Device evaluation: 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) (emdr 3001845648-2023-00458) which 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.Refer to the returned product-notes field for lab attendance and lab evaluation notes.The returned device lab examination findings and observations can be referred through attached photos.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: as per the instructions for use ifu0091 which accompanies this device, informs the user, that stent migration is listed as a potential adverse event of this device.It also states ¿determine the proper stent size after complete diagnostic evaluation.Note: selection of inappropriate stent diameter and length based on lesion and vessel characteristics could lead to stent migration¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review: images were not returned for evaluation.It was asked of the user if images were available to which they replied that there was but after numerous requests, none were acquired.It has been stated that they were checking if they can be forwarded but that this is a lengthy process and they would inform us should the images be released.Unfortunately due to legal reasons, the images were not provided to us.Root cause analysis a definitive root cause could not be determined from the available information.A possible root cause could likely be attributed to an inappropriate stent size selection as the diameter of the stent might possibly be smaller than that of the vein.An image review would be required to confirm this but as of yet, images have not been submitted for review.The returned stent was observed to be fractured when evaluated in the lab.Upon request for clarification on when this fracture happened, the user has stated that they were unsure of when the fracture occurred as he does not have images of it fractured so it most likely happened when the stent was being removed from the patient.As per the ifu, selection of inappropriate stent diameter and length based on lesion and vessel characteristics could lead to stent migration.Also, it should also be noted the ifu0091 lists stent migration as a potential adverse event.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the initial reporter 01 stent was implanted in the iliac vein with no complications in (b)(6) 2022.In (b)(6)2023, the patient was scanned and the stent was still in place in the intended location.2 months later the patient went to the emergency room for pancreatitis.The patient was given a ct scan for his pancreatitis.It was incidentally discovered that the zilver stent was no longer in the iliac vein and had migrated to the right ventricle.Confirmed quantity of 01 device, confirmed used.The patient went to the emergency room for pancreatitis.They went to the er and received a ct scan where the migration was discovered.It was discovered that the zilver stent was no longer in the iliac vein and had migrated to the right ventricle.The product had to be surgically removed from the patient.Investigation findings conclude a definitive root cause was not established.A possible root cause could likely be attributed to an inappropriate stent size selection as the diameter of the stent might possibly be smaller than that of the vein complaint is confirmed based on customer and/or rep testimony.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 the 03-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: 16909794
• MDR Text Key: 314974172
• Report Number: 3001845648-2023-00339
• 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,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• 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: 04/14/2023
• 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
• Patient Outcome(s): Required Intervention