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 Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 06/08/2023

Event Type  Injury  

Event Description

Background: nonthermal endovenous closure techniques are routinely utilized to treat superficial axial venous reflux.Cyanoacrylate closure is a safe and effective modality implemented for truncal closure.However, an adverse reaction of type iv hypersensitivity (t4h), unique to cyanoacrylate, is a known risk.This study aims to evaluate the real-world incidence of t4h and examine risk factors that may predispose its development.Methods: a retrospective review between 2012e and 2022 was performed at four tertiary us institutions to examine patients who underwent cyanoacrylate vein closure of their saphenous veins.Patient demographics, comorbidities, ceap (clinical [c], etiological [e], anatomical [a], and pathophysiological [p]) classification, and periprocedural outcomes were included.The primary endpoint was development of t4h post procedure.Logistic regression analysis for risk factors predictive of t4h was performed.Variables with a p-value of 0.001) and 4 (p ¼ 0.005) classifications as independent risk factors associated with development of t4h.Conclusions: this real-world multicenter study shows the overall incidence of t4h to be 10%.Ceap 3 and 4 patients of younger age and smokers predicted a higher risk of t4h to cyanoacrylate.

Manufacturer Narrative

Literature title: type iv hypersensitivity reaction after cyanoacrylate venous closure ann vasc surg 2023; 95: 218¿223 https://doi.Org/10.1016/j.Avsg.2023.06.002 2023 the author(s).Published by elsevier inc.This is an open access article under the cc by license (http://creativecommons.Org/licenses/by/ 4.0/).Manuscript a2 average age a3 majority gender b3 date of publication.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: 18373197
• MDR Text Key: 331184212
• Report Number: 9612164-2023-06146
• 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
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 12/15/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Female