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 Restenosis (4576)

Event Date 04/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Bérczi et al 2020 ¿ ¿early and long-term results of the endovascular treatment of patients with isolated infrarenal aortic stenosis¿.Access was obtained through common femoral (n = 39) or brachial artery (n = 1) puncture, then diagnostic angiography was per-formed.Significant stenosis was defined as >70% luminal narrowing.The aortic stenoses were negotiated with a 0.035-inch guidewire.After crossing of the lesion, patients underwent either percutaneous transluminal angioplasty (pta) or stenting (selective, primary, or direct).Self-expanding stents were oversized by 10%.(zilver vena n=1).Significant (70%) restenosis was found in three patients (8%), one in the pta subgroup and two in the stenting sub-group.One restenosis was left untreated because its symptoms did not have a severe impact on quality of life of the patient and the grade of restenosis showed no in-crease during the last 6 years.Reintervention (pta with a plain balloon, n = 1; stent implantation, n = 1) was performed in two symptomatic patients (5%).This file will capture off label use of zilver vena for isolated infrarenal aortic stenosis and potential complication of restenosis.One restenosis was left untreated because its symptoms did not have a severe impact on quality of life of the patient and the grade of restenosis showed no in-crease during the last 6 years.Reintervention (pta with a plain balloon, n = 1; stent implantation, n = 1) was performed in two symptomatic patients (5%).

Manufacturer Narrative

Common name - qan.Product code - qan.Pma/510(k) # p200023.Device evaluation the unknown device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review.As the rpn and lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zvt7 devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl it should be noted that the instructions for use, ifu0047 ,states the following: ¿the zilver vena venous stent is intended for use in the iliofemoral veins for the treatment for symptomatic venous outflow obstruction¿.There is evidence to suggest the user did not follow the ifu.Root cause review.A definitive root cause of off label use was identified from the available information.It is known that the zilver vena was used for isolated infrarenal aortic stenosis.However, as per ifu, ¿the zilver vena venous stent is intended for use in the iliofemoral veins for the treatment for symptomatic venous outflow obstruction¿.Summary.The complaint is confirmed based on customer testimony.According to the initial reporter, the patient may have experienced adverse effects due to this occurrence.There is potential that the patient may have suffered restenosis due to this occurrence.It is known that surgical reintervention was performed on two symptomatic patients.It is possible that the zilver vena device may have been implanted in one of the two symptomatic patients who required surgical intervention due to restenosis.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final mdr being submitted due to competion of the investigation on 29-jul-2022.

• 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: 14575119
• MDR Text Key: 293549094
• Report Number: 3001845648-2022-00338
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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: 04/24/2020
• 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