MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; Stent, iliac vein

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 10/19/2021

Event Type  Injury  

Event Description

Morris et al 2021 ¿ ¿performance of open and closed cell laser cut nitinol stents for the treatment of chronic iliofemoral venous outflow obstruction in patients treated at a single centre¿.When stenting across the inguinal ligament was required, an appropriate distal landing zone above the confluence of the femoral vein (fv) and profunda femoral vein (pfv) was identified using ivus, no stents were extended into the fv or pfv.Selected patients with extensive common femoral and inflow disease had an endophlebectomy and temporary arteriovenous fistula created to improve flow through the stent system.Re-interventions were performed for symptom recurrence, in stent stenosis >50% or stent occlusion identified on duplex ultrasound.Thrombolysis (1); venoplasty (1); stent extension (2).

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Zilver vena product code: qan; 510k #: p200023.

Manufacturer Narrative

Zilver vena product code: qan.510 k # p200023.Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.This file is related to pr 362914 (3001845648-2022-00342).Document review: prior to distribution all zilver vena devices are subjected to a visual and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown historical data was not reviewed as the lot number is unknown.It should be noted that the instructions for use (ifu0047-5) lists restenosis and thrombosis as potential adverse events.There is no evidence to suggest that the customer did not follow the instructions for use.There is no evidence to suggest that the customer did not follow the label.Root cause review: a definitive root cause could not be determined.A possible root cause could be attributed to patient pre-existing conditions and/or known potential complications.Based on the inclusion criteria for the study, it is know that the patients pre-existing conditions included the following: confirmed supra-inguinal venous outflow obstruction with >50% reduction in iliac vein diameter, villalta score > 5 and/or significant venous claudication.It should be noted that restenosis and thrombosis of the stented vein are known potential adverse events which are listed in the instructions for use.Summary: the complaint is confirmed based on customer testimony.The literature paper compared the performance of open and closed cell laser cut nitinol stents for the treatment of chronic iliofemoral venous outflow obstruction in patients treated at a single centre.The paper reported that 04 of the 16 zilver vena stents experienced the need for reintervention at 12 months; 1 thrombolysis, 1 venoplasty and 2 stent extension.As per medical advisor 're-interventions were performed for symptom recurrence', the paper concluded that results were comparable for open cell vs closed cell stents.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.

• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 14590214
• MDR Text Key: 293262552
• Report Number: 3001845648-2022-00339
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/19/2021
• Event Location: Hospital
• Date Manufacturer Received: 05/09/2022
• 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