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 Pulmonary Embolism (1498); Unspecified Infection (1930); Local Reaction (2035); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

Literature title: serious adverse events with cyanoacrylate closure of varicose veins: an initial report from a large-scale national survey in japan december 2023 annals of vascular diseases doi: 10.3400/avd.Oa.23-00106 license: cc by-nc-sa 4.0 b3 date of acceptance 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.

Event Description

Abstract objective: cyanoacrylate closure (cac) is a minimally invasive technique for the treatment of varicose veins.A recent paper reported serious adverse events (aes) associated with this use.This triggered an urgent survey to determine the incidence of aes in japan.Methods: the cac-ae survey was sent to all 1,030 institutions authorized for cac treatments.Cases performed between (b)(6) 2020 and (b)(6) 2023 were surveyed.Data on serious aes and mortality were collected.Results: there were 623 surveys returned.There were 16 cases of proximal deep vein thrombosis, 3 cases of pulmonary embolism (pe), and 0 cases of stroke.Deep vein occlusion due to cyanoacrylate extension was observed in 1 case.Vein resection due to infection was observed in 4 cases.There were 299 cases of localized phlebitis and/or allergic reactions requiring steroid administration.Systemic allergic reactions requiring steroid administration were observed in 66 cases.There was no anaphylaxis associated with cyanoacrylate.There was one postoperative death from pe.Conclusion: this report¿s intent is to provide real world data on serious aes following cac from japan given current concern over these events.An extensive report investigation of individual complications with analysis including causality will be provided following a full investigation separately.

• 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: 18324924
• MDR Text Key: 330485457
• Report Number: 9612164-2023-05960
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 12/10/2023
• 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