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

Catalog Number ZVT7-35-80-14-100

Device Problems Deformation Due to Compressive Stress (2889); Migration (4003)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to customer relations via phone conversation "deployment went great the day of the case.There was a minor amount of clot a couple day post surgery.Afterwards, the patient seemed be doing fine.Now, the patient seemed to be under alot of pain.It seems the stent has shifted down and narrowed.The dm is inquiring if images are available to confirm and provide more clarity." patient outcome did any unintended section of the device remain inside the patient¿s body? please describe the object and how it was retrieved: did the patient experience a delay or require any additional procedure due to this occurrence? 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? has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Patient/event info - notes: are images of the device or procedure available? n/a, yes, no.Did the patient have pre-existing conditions? n/a, yes, no.If yes, please specify: 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: was a stent previously placed during previous procedures? n/a, yes, no.Was the device used percutaneously? n/a, yes, no.Where on the patient was the percutaneous access site? was the access site jugular or femoral? n/a, jugular, femoral other.If other, please specify: what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral.Was pre-dilation performed ahead of placement of the stent? n/a, yes, no.What was the target location for the stent? details of access sheath used (name, fr size, length)? was the device flushed through both flushing ports before the procedure, as per ifu? n/a, yes, no.Details of the wire guide used (name, diameter, hyrdophyllic)? was resistance encountered when advancing the wire guide to the target location? n/a, yes, no.Was resistance encountered when advancing the delivery system to the target location? n/a, yes, no.If resistance was met, how did the physician address this? did the tip of the delivery system cross the target location? n/a, yes, no.Did the user pull the handle towards the hub during deployment, per ifu? n/a, yes, no.Did the user push the hub during deployment? n/a, yes, no.Did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no.Was the stent deployed smoothly / without resistance? n/a, yes, no.Was the stent fully deployed in the patient? n/a, yes, no.Was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no.Was post dilation performed after the placement of the stent? n/a, yes, no.Was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no.What intervention (if any) was required? 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.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no.Please specify if yes.

Event Description

Supplemental report is being submitted due to the completion of imaging review on 22-mar-2022.Findings: the complaint concerns distal stent movement and narrowing discovered eight months post implantation and associated with pain.Imaging of this event was not provided.Impression: 1.The complaint is not confirmed as imaging of the event was not provided.2.The stent was likely implanted approximately 2cm shorter than its design length in a non-thrombotic localized may thurner lesion.No impact on ae assessment.Remains reportable based on 'stent migration' follow up mdr scheduled to capture imaging review.Confirmation received on 05-apr-2022 that pelvic pain and narrowing of stent under ultrasound is referring to zvt7-35-80-14-100 in this file.Stent compression with zvt7-35-80-14-100 is also confirmed.As per second imaging review on 06-apr-2022: the complaint of stent narrowing in a left civ and right cia may thurner lesion is confirmed.The stent was flattened 40% between the right cia and the spine at eight months.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of imaging review on 30-sept-2022.Imaging review updated on 20-sept-2022: the complaint of stent narrowing in a left civ and right cia may thurner lesion is confirmed.The stent was flattened 40% between the right cia and the spine at 8 eight months.The reported new pain is assumed to be consistent with and secondary to the 30% reduction in the vein cross sectional area.

Event Description

Supplemental report being submitted due to the completion of the investigation on 27-apr-2023.

Manufacturer Narrative

Pma 510k #p200023.Device evaluation the zvt7-35-80-14-100 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation ¿ n/a.Document review as the lot number of the complaint stents is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zvt7-35-80-14-100 devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is no evidence to suggest the user did not follow the instructions for use.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 (image review, version 2): the complaint of stent narrowing in a left civ and right cia may thurner lesion is confirmed.The stent was flattened 40% between the right cia and the spine at eight months.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing condition, may thurner.The may thurner lesion may have exerted compressive stress on the stent, leading to stent narrowing over time.Summary: complaint is confirmed as the failure was verified in the image(s).Stent narrowing was observed in the imaging review.According to the initial reporter, the patient required additional surgery due to this occurrence.The second procedure was required to correct the compression.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: 13058417
• MDR Text Key: 289967800
• Report Number: 3001845648-2021-00891
• Device Sequence Number: 1
• Product Code: QAN
• 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,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVT7-35-80-14-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female