MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Unspecified Infection (1930); Pain (1994); Phlebitis (2004); Paresthesia (4421); Thrombosis/Thrombus (4440)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Chronic venous disease (cvi) and varicose veins arecommonly treated entities that have significant psychosocial and economic impact.1 the great saphenous vein (gsv) commonly develops valvular incompetence and reflux leading to distal venous hypertension with its adverse sequalae of superficial thrombophlebitis, deep vein thrombosis (dvt), and cutaneous ulceration and, therefore, has been the focus of therapy for many years.2 whereas surgical vein ligation and stripping was previously the only reliable method to address gsv incompetence, this surgical procedure gradually has been replaced due to the development of a variety of minimally invasive procedures which have equivalent or better long-term outcomes with less short-term complications and cost.1,2 foremost among these procedures are tumescent anesthesia assisted endovenous thermal ablation with laser or radiofrequency (evta).The endovenous laser therapy (evlt) procedure developed by dermatologic surgeons, robertweiss andmitchel goldman, brought together their knowledge of tumescent liposuction, laser surgery, and ambulatory phlebectomy revolutionized vascular surgery of the venous system.Additional treatments include catheter-directed or ultrasound-guided foam sclerotherapy and endovenous cyanoacrylate adhesive vein closure which do not require tumescent anesthesia.3 more recently, there are reports of tumescent-assisted catheterdirected foam sclerotherapy (cdfs).Cyanoacrylate adhesive a proprietary cyanoacrylate adhesive (venaseal, medtronicplc, dublin, ireland) has been developed for permanent closure of incompetent superficial truncal leg veins and wasfda-approved in 2015.12 the adhesive is delivered through a hydrophobic catheter advanced to a point 5 cm below the sfj.Cyanoacrylate adhesive (ca) triggers an acute inflammatory reaction in the vessel wall using a polymerization reaction leading to encapsulation and vein fibrosis.12in the first human use of endovenous ca for closure of insufficient gsvs, 38 subjects at a single center with symptomatic gsv reflux treated with ca had a 92% 12- month target vein closure rate.13 a clinical trial across 10 centers in the united states14 randomized 222 patients to ca or radiofrequency ablation (rfa).The anatomic success rate was 100%, 97%, and 97% for ca and 87%, 94%, and 97% for rfa, at 48-hour, 3-month, and 1-year follow-up.The anatomic results for the ca group were proven noninferior to the rfa group.No serious adverse events occurred in either group, and no postprocedural dvt or thrombus extensions into the common femoral vein were identified.Adverse events were limited to phlebitis, paresthesia, pain during the procedure, access site infection, and ecchymosis.Postprocedure compression stockings were used in both groups for 3 days continuously and an additional 4 days during waking hours.Another retrospective review of patients who underwent ca treatment or rfa during a 3-year period showed a treatment success of 99% and 100% in the groups, respectively.15 one patient in each group had asymptomatic proximal thrombus extension treated with anticoagulation for 2 to 3 weeks.Three superficial infections from glue clumps were noted in the ca group requiring excision and drainage.Chronic foreign body reaction has also been reported in ca-treated patients.16 one concern is the possibility of recanalization of the treated vein with ca, especially inveins larger than 6.6 mm.17.

Manufacturer Narrative

Literature title large varicose vein closure: a comprehensive review varicose vein management dermatologic surgery ¿ september 2022 ¿ volume 48 ¿ number 9 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15735022
• MDR Text Key: 303076221
• Report Number: 9612164-2022-04064
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2022
• 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