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

Model Number G57449

Device Problems Off-Label Use (1494); Deformation Due to Compressive Stress (2889)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # (b)(4).Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

A patient had failed anticoagulation and thrombectomy twice and was coming back for mechanical thrombectomy and stent placement due to may thurner.After removing all the clot, we measured the vessel with ivus and placed a 16x140 vena.Unfortunately, the stent was so compressed that on a lateral projection, it was measuring 23mm in diameter.We pre dilated with a 12mm balloon and post dilated with a 14mm balloon but that didn¿t seem to help.The patient received and second stent, 16x80 abre, to help open the vessel.This provided satisfactory results.Patient outcome : 1.Did any unintended section of the device remain inside the patient¿s body? no.2.Was the patient hospitalized or was there prolonged hospitalization? no.3.Did the patient require any additional procedures due to this occurrence? no.4.Did the product cause or contribute to the need for additional procedures? no.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no, an additional stent just had to be placed.6.Has the complainant reported that the product caused or contributed to the adverse effects? no.Patient/event info - notes: the following information has been received via email on (b)(6) 2023.Sg (b)(6)2023.Did the patient have pre-existing conditions? failed anticoagulation and thrombectomy twice and was coming back for mechanical thrombectomy and stent placement due to may thurner.What disease pathology was being treated? may thurner.Was pre-dilation performed ahead of placement of the stent? yes.The following information has been requested via email on (b)(6)2023.Sg (b)(6)2023.10.Are images of the device or procedure available? 11.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.If other, please specify: 12.Was a stent previously placed during previous procedures? 13.Was the device used percutaneously? 14.Where on the patient was the percutaneous access site? 15.Was the access site jugular or femoral? n/a, jugular, femoral other if other, please specify: 16.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral 17.What was the target location for the stent? 18.Details of access sheath used (name, fr size, length)? 19.Was the device flushed through both flushing ports before the procedure, as per ifu? 20.Details of the wire guide used (name, diameter, hyrdophyllic)? 21.Was resistance encountered when advancing the wire guide to the target location? 22.Was resistance encountered when advancing the delivery system to the target location? 23.If resistance was met, how did the physician address this? 24.Did the tip of the delivery system cross the target location? 25.Did the user pull the handle towards the hub during deployment, per ifu? 26.Did the user push the hub during deployment? 27.Did the user remove slack in the delivery system before deployment, per ifu? 28.Was the stent deployed smoothly / without resistance? 29.Was the stent fully deployed in the patient? 30.Was the stent fully deployed before removing the delivery system from the patient? 31.Was post dilation performed after the placement of the stent? 32.Was the delivery system damaged/kinked/twisted during deployment? 33.What intervention (if any) was required? 34.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 35.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 (b)(6) 2023.Sg (b)(6) 2023 10.Are images of the device or procedure available? in the reply email s a screenshot of ivus after the stent was deployed.You can tell the vessel is still very narrowed.We had to place an abre which has more radial force to open the vessel.11.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: the vessel was stenosis with chronic clot.The doctor pre-dilated to 12mm 12.Was a stent previously placed during previous procedures? no.13.Was the device used percutaneously? yes.14.Where on the patient was the percutaneous access site? popliteal.15.Was the access site jugular or femoral? n/a, jugular, femoral other.A.If other, please specify: popliteal vein.16.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral: ipsilateral.17.What was the target location for the stent? proximal common femoral vein.18.Details of access sheath used (name, fr size, length)? 8 fr sheath; terumo pinnacle.19.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.20.Details of the wire guide used (name, diameter, hyrdophyllic)? unsure.21.Was resistance encountered when advancing the wire guide to the target location? minimal.22.Was resistance encountered when advancing the delivery system to the target location? minimal.23.If resistance was met, how did the physician address this? 24.Did the tip of the delivery system cross the target location? yes.25.Did the user pull the handle towards the hub during deployment, per ifu? yes.26.Did the user push the hub during deployment? no.27.Did the user remove slack in the delivery system before deployment, per ifu? yes.28.Was the stent deployed smoothly / without resistance? yes.29.Was the stent fully deployed in the patient? yes.30.Was the stent fully deployed before removing the delivery system from the patient? yes.31.Was post dilation performed after the placement of the stent? yes up to 14mm.32.Was the delivery system damaged/kinked/twisted during deployment? no.33.What intervention (if any) was required? an additional stent with more radial force.34.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: no.35.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.No.

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 follow-up mdr report is being submitted due to the receipt of image review on 24-mar-23.

Manufacturer Narrative

Pma 510k #p200023.Device evaluation: off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Trending will monitor if any future investigation is required.The zvt7-35-80-16-140 device of lot number c1996586 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.An additional pr (b)(4) was raised to capture the user error of the incorrect size access sheath used during the procedure.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.Ifu/label review as per the instructions for use (ifu0091), it states that the potential effects of phthalates on pregnant women/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.The intended use outlined in the ifu is as follows: " the zilver vena venous stent is indicated for improving luminal diameter in the the iliofemoral veins for the treatment of symptomatic venous outflow obstruction" as per the ¿target groups¿ section of the technical content form (itf051 d00313728) associated with this device, this stent is for use on adults patients with symptomatic iliofemoral venous outflow obstruction the compression of the stent could have been caused by the placement of the device in the iliac vein of a 13 year old as the iliac vein diameter would be smaller when compared to that of an adult.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 the complaint of civ stent compression between the left cia and spine is confirmed.The overlying right cia, the chronic fibrotic scarring of two thrombotic events, and an often normal flat to ovoid shape of the cranial left civ resisted stent expansion.Root cause review a definitive root cause of off label use was identified from the available information.It was noted from the patient information received that the patient was 13 years old at the time of the event.The compression of the stent could have been caused by the placement of the device in the iliac vein of a 13 year old as the iliac vein diameter would be smaller when compared to that of an adult.As the device is not designed, or has had any engineering testing to support paediatric use, it is therefore unknown how it will function outside of its intended target population of adult patients.The patients anatomy also would have contributed to the compression.The overlying right cia, the chronic fibrotic scarring of two thrombotic events, and an often normal flat to ovoid shape of the cranial left civ resisted stent expansion.The user has not complied with the requirements of the ifu with respect to the intended use of the device.As per (b)(4), rev006, section 5.3 table 1 - off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.As the device was used outside of their validated state and/or against the instructions provided in the ifu, it is not possible to predict how the devices will perform or function.Confirmation of complaint complaint is confirmed as the failure was verified in the images.Summary according to the initial reporter the patient had failed anticoagulation and thrombectomy twice and was coming back for mechanical thrombectomy and stent placement due to may thurner.After removing all the clot, they measured the vessel with ivus and placed a 16x140 vena.Unfortunately, the stent was so compressed that on a lateral projection, it was measuring 23mm in diameter.They pre dilated with a 12mm balloon and post dilated with a 14mm balloon but that didn¿t seem to help.The patient received a second stent, 16x80 abre, to help open the vessel.This provided satisfactory results.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient the patient received a second stent to help open the vessel which provided satisfactory results.Investigation findings conclude that a definitive root cause was established.The user has not complied with the requirements of the ifu with respect to the intended use of the device.It was noted from the patient information received that the patient was 13 years old at the time of the event.A 13 year old iliac vein diameter would be smaller when compared to that of an adult and would have contributed to stent compression.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 16 june 2023.

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 follow-up mdr report is being submitted due to the clinical input received on (b)(6) 2023.Clinical input received as follows: off label use placement in a 13 year old patient.Imdrf codes updated to reflect.No adverse effect to the patient was reported as occurring.Reportable based on off-label use of the device and the potential for injury to occur if the event was to recur.

• 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: 16589026
• MDR Text Key: 312306296
• Report Number: 3001845648-2023-00180
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)251111(10)C1996586
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• 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: C1996586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2023
• Event Location: Hospital
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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 Age: 13 YR
• Patient Sex: Male