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 Pulmonary Embolism (1498); Insufficient Information (4580)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

Device common name: qan.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: maes after 30 days: included 7 events of clinically driven reinterventions and 1 event of new symptomatic pe (pulmonary embolism) maes after 12 months: specifically, 10 events of clinically driven target lesion reintervention, and 2 events of new symptomatic pe.Per medical affairs input: require intervention/additional procedures.243 patients.Average age: 53 years.Gender: female 170, male 73.

Manufacturer Narrative

Common name: (b)(4).Pma/510(k) # p200023 pma/510(k.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

A supplemental report is being submitted as a correction brief description updated, description of events updated, qty updated, imdrf codes updated.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation on 31-mar-23 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) ( mdr ref.- 3001845648-2023-00116 ) , (b)(4) ( mdr ref.- 3001845648-2023-00117 ) , (b)(4) ( mdr ref.- 3001845648-2023-00119) , (b)(4) ( mdr ref.- 3001845648-2023-00198 ) , (b)(4) (mdr ref.- 3001845648-2023-00197) , (b)(4) ( mdr ref.- 3001845648-2023-00196 ) and it was created from the attached journal.Article.This complaint captures the possibility that the event occurred in the us while (b)(4)captures the possibility that the event occurred in the taiwan.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.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 lists pulmonary embolism 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 review: a definitive root cause could not be determined however a possible root cause could be attributed to patient pre-existing conditions which included risk factors for pulmonary embolism of coronary artery disease and clotting disorder.As previously noted, pulmonary embolism is listed as a potential adverse event in the ifu.Summary: the complaint is confirmed based on customer testimony.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, pulmonary embolism was reported in 01 patient within 30 days, the treatment was not reported in the article however it is likely that this will have resulted in an intervention.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: 16400822
• MDR Text Key: 309874595
• Report Number: 3001845648-2023-00118
• 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,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/06/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 01/20/2023; 01/20/2023
• Supplement Dates FDA Received: 03/30/2023; 04/27/2023
• 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