MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Notten et al 2020 ¿ quality of anticoagulant therapy and the incidence of in-stent thrombosis after venous stenting objectives: to determine the association between the quality of postinterventional vka treatment and the occurrence of in-stent thrombosis.Patients were recruited from a cohort study that was followed at the maastricht university medical centre, the netherlands, between march 2009 and january 2013.Seventy-nine of the 108 eligible patients (73.1%) provided informed consent to retrieve additional data from their individual anticoagulation clinic and could therefore be included in this study.Forty (50.6%) patients had a ¿low¿ target inr (inr range, 2.0-3.5) and 39 (49.4%) patients had a ¿high¿ target inr (inr range, 2.5-4.0).Indications for venous stent placement were classified as either acute cavo-iliofemoral thrombosis, or chronic deep venous obstruction due to the presence of postthrombotic sequelae (ie, pts with postthrombotic synechiae), or (nonthrombotic) iliac vein compressionsyndromes.Patients were treated with pta and stenting.Stenting in the acute thrombotic phase was usually performed following treatment with ultrasound-accelerated cdt.Self-expandable stents with diameter sizes ranging from 12 to 16 mm in the iliofemoral tract to 24 mm in the caval tract were used in all cases: sinus-xl, sinus-xl flex, sinus-venous (optimed), zilver vena (cook).To reconstruct the confluence of the vena cava in the limited number of patients with bilaterally affected iliac tracts, balloonexpandable stents such as the andrastent (andramed) were used off-label use of the zilver vena stent in the vena cava.Use of the device is the caval and azygos veins were confirmed off-label by the medical officer.As per the ifu device is intended for use in the iliofemoral veins.In-stent thrombosis developed in 16 patients (20.3%) after a median of 67.0(6.0-264.5) days within a median follow-up of 1200 (1037-1363) days.4 patients (25.0%) were stented during the acute post thrombotic phase.12 (75.0%) patients were stented for chronic post-thrombotic deep venous obstruction.Potentially 5 cases of in-stent thrombosis could be related to off-label use.

Event Description

Final mdr due to the completion of investigation on (b)(6) 2021.

Manufacturer Narrative

Pma/510(k) #: p200023.Section d: common name - qan.Device evaluation: the zilver vena venous self-expanding stent devices (zvt7) of unknown lot numbers involved in this complaint were implanted in the patients and were 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 stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver vena venous self-expanding stent devices are subject to 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 (ifu0047-5 ) states the following: intended use: the zilver vena venous stent is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.There is evidence to suggest the user did not follow the instructions for use as the information available indicates that the stents were used in the caval and azygos veins.Root cause review: a definitive root cause of off labe use was identified from the available information.The information available indicates that the stents were used in the caval and azygos veins.The zilver vena venous stent is intended for use in the iliofemoral veins.It is not possible to state how the device will perform when used outside of its validated state.Potentially 5 cases of in-stent thrombosis could be related to off-label use.Summary: the complaint is confirmed based on customer testimony.The outcome for the patients is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11932221
• MDR Text Key: 281358044
• Report Number: 3001845648-2021-00431
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 07/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/08/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR