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

Model Number G57449

Device Problems No Apparent Adverse Event (3189); Migration (4003)

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

Event Date 03/06/2023

Event Type  Injury  

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

Per rep - (b)(6), 2023 - left access.Mid femoral vein.They stented the left iliac vein due to may thurner syndrome.The stent ended up migrating due to additional product being inserted into the body for the procedure.They were able to fixate the stent at the compression point and they laid another stent in to prevent migration.Per rep - (b)(6), 2023 - scheduled unilateral venogram with possible stent.Access to left mid femoral vein with 9fr sheath.Ivus and pre-balloon angioplasty was used.Physician went ahead and stented with a 16x140 zilver vena in the left common iliac vein and planned to extend with a 20 z stent into the ivc.While introducing the z stent introducer into the body, the patient moved on the table.The wire was pulled back and misplaced due to the patient moving.When using fluoro watching the z stent introducer advance, i noticed that the zilver vena stent had shifted up into the ivc and it looked like the wire was going through the strut of the stent and the z stent introducer.I had told the physician to stop what he was doing so that would not advance the stent any further.We carefully planned out what we were going to do next to get the stent lower into the ivc.We took a 16mm bard atlas balloon and inflated in the stent to draw the stent distally, it took a couple of tried with the 16mm and 18mm balloon, but we were able to get the proximal edge of the stent to the middle of l1 segment and lined the distal segment of stent with an 18mmx100mm medtronic abre stent (extending into the left external vein).Md will follow up in 3 days with patient.Patient outcome : 6.3.1.1 did any unintended section of the device remain inside the patient¿s body? -no? if yes, please describe.6.3.1.2 was the patient hospitalized or was there prolonged hospitalization due to this occurrence? -no.6.3.1.3 did the patient require any additional procedures due to this occurrence? -no if yes, please describe.6.3.1.4 did the product cause or contribute to the need for additional procedures? -no if yes, please specify additional procedures and provide details.6.3.1.5 has the complainant reported any adverse effects on the patient due to this occurrence? -no 6.3.1.6 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: prefix zvt7 3.91 are images of the device or procedure available? n/a, yes, no -investigators should reach to rep regarding images.3.92 did the patient have pre-existing conditions? n/a, yes, no -may thurner syndrome if yes, please specify: 3.93 please describe the native state of the vessel (i.E.Was the anatomy tortuous? -may thurner syndrome.Was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other if other, please specify: -may thurner syndrome.3.94 was a stent previously placed during previous procedures? n/a, yes, no -no 3.95 was the device used percutaneously? n/a, yes, no -yes.3.96 where on the patient was the percutaneous access site? -left mid femoral vein 3.97 was the access site jugular or femoral? n/a, jugular, femoral other -femoral if other, please specify: 3.98 what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? -may thurner if other, please specify 3.99 was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral -ipsilateral 3.100 was pre-dilation performed ahead of placement of the stent? n/a, yes, no -yes 3.101 what was the target location for the stent? left common iliac vein 3.102 details of access sheath used (name, fr size, length)? -boston scientific 9 fr, 11 cm 3.103 was the device flushed through both flushing ports before the procedure, as per ifu? n/a, yes, no -yes 3.104 details of the wire guide used (name, diameter, hyrdophyllic)? -boston scientific benson.035 by 180, not hydro 3.105 was resistance encountered when advancing the wire guide to the target location? n/a, yes, no -no 3.106 was resistance encountered when advancing the delivery system to the target location? n/a, yes, no -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? n/a, yes, no -yes 3.109 did the user pull the handle towards the hub during deployment, per ifu? n/a, yes, no -yes 3.110 did the user push the hub during deployment? n/a, yes, no -no.3.111 did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no -yes 3.112 was the stent deployed smoothly / without resistance? n/a, yes, no -yes 3.113 was the stent fully deployed in the patient? n/a, yes, no -yes 3.114 was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no -yes.3.115 was post dilation performed after the placement of the stent? n/a, yes, no -no 3.116 was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no -no.3.117 what intervention (if any) was required? -none at this time 3.118 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 -same procedure 3.119 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.

Event Description

This follow up mdr is being submitted to capture the image review received on 03-apr-2023: image review: impression: 1.The complaint of a displaced zvt7-35-80-16-140 stent is confirmed.2.The image is consistent with the reported guidewire repositioning through the zvt7 interstices followed by zvt7 displacement into the ivc by z-stent introducer advancement.3.The zvt7 superior end could extend over one or both renal vein ostia.

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

Supplemental report is being submitted due to the completion of the investigation on (b) (6) 2023.

Manufacturer Narrative

Pma/510(k) #p200023.Device evaluation the zvt7-35-80-16-140 device of lot number c1957715 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.This pr is related to pr 394176 which was raised to capture user error ¿ wrong access sheath size.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.An nc (gen-006) was noted on the work order but this unit was subsequently scrapped and would not have contributed to this 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.It should be noted that the instructions for use (ifu0091) states the following: ¿use caution when re-crossing a stent to avoid stent damage or migration¿.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression: 1.The complaint of a displaced zvt7-35-80-16-140 stent is confirmed.2.The image is consistent with the reported guidewire repositioning through the zvt7 interstices followed by zvt7 displacement into the ivc by z-stent introducer advancement.3.The zvt7 superior end could extend over one or both renal vein ostia.Root cause analysis no root cause determination is required as the complaint is not confirmed.This issue occurred as the patient moved on the table, misplacing the guidewire causing the stent to migrate.This occurred after the zvt7 had been placed successfully.Then while introducing the z stent introducer into the body, the patient moved and caused the guide wire to be retracted into the zvt7, which led the z stent introducer to push the zvt7 stent towards ivc.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 they stented the left iliac vein due to may thurner syndrome.The stent ended up migrating due to additional product being inserted into the body for the procedure.They were able to fixate the stent at the compression point and they laid another stent in to prevent migration.The physician stented with a zilver vena in the left common iliac vein and planned to extend with a 20 z stent into the ivc.While introducing the z stent introducer into the body, the patient moved on the table.The wire was pulled back and misplaced due to the patient moving.When using the fluoro to watch the z stent introducer advance, it was noticed that the zilver vena stent had shifted up into the ivc and it looked like the wire was going through the strut of the stent and the z stent introducer.They took a bard atlas balloon and inflated in the stent to draw the stent distally and eventually were able to get the proximal edge of the stent to the middle of l1 segment and lined the distal segment of stent with a medtronic abre stent.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.They were able to fixate the stent at the compression point and they laid another stent in to prevent migration.Investigation findings conclude that this complaint is not confirmed.This issue occurred as the patient moved on the table, misplacing the guidewire causing the stent to migrate.This occurred after the zvt7 had been placed successfully and the zvt7 did not cause or contribute to this issue.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.

• 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: 16662688
• MDR Text Key: 312501158
• Report Number: 3001845648-2023-00204
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)250707(10)C1957715
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1957715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2023
• Event Location: Hospital
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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
• Patient Age: 25 YR
• Patient Sex: Female