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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); Restenosis (4576)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

Common name: (b)(6).Pma/510(k) # p200023 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Hofmann 2022 - 12- month endpoint results from the evaluation of the zilver vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (vivo clinical study) two-view venography was performed to assess the study lesion characteristics (e.G., location, minimum lumen diameter [mld]) and to assist with stent sizing.Intravascular ultrasound (ivus) was not considered standard of care during study design development and was not required per the protocol.Mld was determined using two venography projections, based on diameter measurements of the narrowest point in the treated segment of vein (the stented segment and 1 cm additional cranial and caudal to the stent).Venographic measurements used a calibration source (either intravascular calibration device(s) or an external calibrated device).Pre-dilation of the vessel and post-stent dilatation were recommended.Stents were recommended to be oversized by 2-4 mm relative to the surrounding vasculature, the expanded balloon diameter used for predilatation, or the standard diameter of the vein to be stented.Stents were recommended to fully cover the lesion and extend into healthy tissue (caudally and cranially) by 5-10 mm.When multiple stents were required, stent overlap by at least 1 cm was recommended.Upon procedure completion, two-view venography was used to evaluate the lesion and stent placement characteristics.Technical success failure: 19 patients had a loss of primary quantitative patency (16 patients with an occlusion and 3 patients with a loss of patency >50%); of note, one occlusion fell beyond the 12 month follow-up window (day 417) and was conservatively included as a failure in the analysis.Per medical affairs input: require intervention/additional procedures 243 patients.Average age: 53 years.Gender: female 170, male 73.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

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).(emdr ref.- 3001845648-2023-00116 ) , (b)(4)., (b)(4)., (b)(4)., (b)(4)., (b)(4).(emdr ref.- 3001845648-2023-00118 ) , (b)(4).Emdr ref.- 3001845648-2023-00119 ) , (b)(4)., (b)(4).,(b)(4)., (b)(4)., (b)(4).(emdr ref.- 3001845648-2023-00198 ) , (b)(4).(emdr ref.- 3001845648-2023-00197 ) , and (b)(4).(emdr ref.- 3001845648-2023-00196 ) and it was created from the attached journal article ref.Att.¿hofmann 2022 literature preliminary review.Msg¿.This complaint captures the possibility that the event occurred in the us, (b)(4).Captures the possibility that the event occurred in taiwan.Manufacturing records review: prior to distribution all zilver vena devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data review: historical data was not reviewed as the lot number is unknown.Instructions for use and label: it should be noted that the instructions for use lists restenosis, occlusion or thrombosis of the stented vein as a potential adverse event.There is no evidence to suggest the user did not follow the ifu or label.Image review : an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined.A possible root cause for loss of patency could be attributed to patient pre-existing conditions which included risk factors for thrombosis or occlusion including coronary artery disease, hypertension, dvt, diabetes and smoking.It is also known that 41 of the 243 patents had a history of cancer.It is possible that tumour ingrowth/overgrowth could have contributed to the loss of patency.As previously mentioned, the ifu lists restenosis, occlusion or thrombosis of the stented vein as a potential adverse event.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: the complaint was raised from literature paper hofmann et al ¿12-month endpoint results from the evaluation of the zilver vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction¿.According to the initial reporter, 19 patients experienced loss of patency requiring intervention.Investigation findings conclude a possible root cause could be attributed to patient pre-existing conditions.The complaint is confirmed based on customer testimony.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: 16397018
• MDR Text Key: 309989752
• Report Number: 3001845648-2023-00117
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2022
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female