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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

Greenberg et al 2023 - reconstruction of upper extremity and thoracic central veins using dedicated venous stents: implantation of 75 stents in 46 patients.This report describes the use of these venous stents in the upper extremity and thoracic central veins.Seventy-five stents were implanted during 52 interventions.Various venous stents were used, including 43 abre, 21 venovo, 7 vici, and 4 zilver vena, based on operator preference and device availability.Overall mean stent diameter was 13.7 ± 2.0mm.Mean stent diameters of abre, venovo, vici, and zilver vena were 13.2 ± 1.8mm, 15.2 ± 1.8mm, 12.3 ± 0.8mm, and 14 ± 0mm, respectively.This complaint captures the off label use of the zilver vena stent - stent placed in upper extremity and thoracic central veins in this study were used off-label.As per ifu0091-8, ¿zilver vena venous stent is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction.¿ fig.4 60-year-old man presented with right upper extremity swelling.A 13-mm × 50-mm viabahn stent-graft (w.L.Gore & associates) was deployed along the right subclavian vein.Next, a 14- mm × 100-mm zilver vena stent was deployed in an overlapping fashion to extend to the svc.In this series, 16 dedicated venous stents were deployed adjacent to or across the thoracic outlet without substantial deformation or fracture on follow-up imaging.While additional studies are warranted, these dedicated self-expanding bare-metal venous stents may be able to tolerate the biomechanical stress across the thoracic outlet and could serve as a viable treatment option for endovascular reconstruction in this challenging anatomy.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # p200023.This file was created from literature " greenberg et al 2023" to capture off label use.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.Manufacturing records: prior to distribution all zilver vena devices are subjected to a visual inspection and functional inspection to ensure device integrity.Review historical data: n/a.Instructions for use and/label: it should be noted that the instructions for use (ifu0091) states the following: "the zilver vena venous stent is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction." there is evidence to suggest the user did not follow the ifu or label.As per medical advisor "4 stents in upper extremity and thoracic central veins - yes, it was off-label use." image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of off label use can be concluded based on the information provided.The information for use states that the device is intended for use in the iliofemoral veins however from the information provided the device was used in the upper extremity and thoracic central veins, this is considered off label use.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer, placement of zilver vena in the upper extremity and thoracic central veins.Confirmed quantity of (b)(4) devices, confirmed used.According to the initial reporter, in this series, 16 dedicated venous stents were deployed adjacent to or across the thoracic outlet without substantial deformation or fracture on follow-up imaging.While additional studies are warranted, these dedicated self-expanding bare-metal venous stents may be able to tolerate the biomechanical stress across the thoracic outlet and could serve as a viable treatment option for endovascular reconstruction in this challenging anatomy.Investigation findings conclude that a definitive root cause of off label use can be concluded based on the information provided.Complaint is confirmed based on customer and/or rep testimony.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 15-aug-2023.

• 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: 17069938
• MDR Text Key: 317133976
• Report Number: 3001845648-2023-00441
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2022
• Event Location: Hospital
• Date Manufacturer Received: 05/08/2023
• 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 Age: 53 YR
• Patient Sex: Female