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 Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 10/26/2022

Event Type  Injury  

Event Description

The main objective of this ambispective, single center, nonrandomized, single-arm, physician-driven study was to evaluate the patency of the zilver® vena¿ venous self-expanding stent (i.E., the zilver® vena¿ venous stent) in patients undergoing venous stenting.This report focuses on data from the 239 patients that had a zilver vena venous stent placed at an index procedure.Patient 112 had restenosis and thrombosis, required imaging and fibrinolysis intervention thrombosis: symptomatic partial thrombosis intrastent, related to zilver vena and related to procedure (restenosis in overlap).Restenosis: imaging modality to diagnose event ultrasound/ct 1st event time to diagnosis 243 days.Not related to device or procedure; minimal restenosis (<50%) + thrombosis due to stop anticoagulation.2nd event time to diagnosis 730 days.Related to device and procedure; restenosis in overlap.Patient 112 had two reinterventions (739 days and 1066 days).Intervention was fibrinolysis.Patient outcome: patient required imaging.Fibrinolysis intervention was required.

Manufacturer Narrative

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

Manufacturer Narrative

Common name: qan.Pma/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 (b)(4).Lab evaluation ¿ n/a.Document review: prior to distribution all zilver vena devices are subjected to a visual inspection and functional inspection to ensure device integrity.It should be noted that the instructions for use (ifu0047) lists restenosis or thrombosis of the stented vein as a potential adverse event.There is no evidence to suggest the user did not follow the ifu.There is no evidence to suggest that the customer did not follow the label.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined however a possible root cause can be attributed to known potential complications associated with the stent placement procedure.As per the article the partial thrombosis was 'related to zilver vena and related to procedure (restenosis in overlap)' as previously mentioned, the ifu lists restenosis or thrombosis of the stented vein as a potential adverse event.Summary: the complaint is confirmed based on customer testimony.The complaint was raised from the clinical study ¿evaluation of the zilver vena venous stent in spain ¿ dr.(b)(6) (physician ¿ driven study ¿ ambispective review of patients undergoing proximal venous stent placement).According to the literature paper, 07 patients experienced restenosis.This complaint captures 01 case of restenosis and partial thrombosis requiring fibrinolysis.The patient experienced restenosis at 243 days which required imaging, this event was 'not related to device or procedure'.At 749 days the patient experienced symptomatic partial thrombosis intrastent with restenosis in overlap requiring fibrinolysis.At 1066 days the patient was treated again with fibrinolysis, the specific complication at this point was not specified.As per medical advisor input ¿require intervention/additional procedure to prevent permanent impairment/damage¿ 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 27jan2023.

• 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: 15864367
• MDR Text Key: 304286924
• Report Number: 3001845648-2022-00801
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• 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: 10/26/2022
• Event Location: Hospital
• Date Manufacturer Received: 10/27/2022
• 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