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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/13/2022

Event Type  Injury  

Event Description

A 66-year-old female presented with 3 weeks of dermatographic urticaria, pruritus and an episode of angioedema following great saphenous varicose vein closure with venaseal closure therapy.Symptoms began on post-operative day (pod) 1 and progressively worsened over 3 weeks.The patient had no known food or drug allergies and had not had similar symptoms prior to this episode.The patient¿s ultrasonography demonstrated reflux of the left lower extremity great saphenous vein, without evidence of deep venous thrombosis.The patient subsequently underwent great saphenous vein closure for superficial venous reflux with pain.On pod 1, the patient noticed pruritus without a rash on the medial aspect of the treated left lower extremity that progressed to include the entire lower extremity over the following 2 weeks.On pod 12, she presented to the emergency department with tongue and lip swelling along with acute onset dyspnea.After a course of oral steroids and antihistamines, she had resolution of angioedema but progression of full body pruritus and development of dermatographism with painful lower extremity erythema and edema.Elevated dosing of antihistamines improved her urticaria and pruritus over the following 2 months, with resolution of pruritis, urticaria, and erythema upon return visit on pod 169.

Manufacturer Narrative

Literature title: hypersensitivity reactions following vein closure therapy with venasealtm (n-butyl2-cyanoacrylate) vascular 2022, vol.0(0) 1¿3 sagepub.Com/journals-permissions doi: 10.1177/17085381221125841 journals.Sagepub.Com/home/vas 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: 15735101
• MDR Text Key: 303076838
• Report Number: 9612164-2022-04065
• 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: 11/04/2022

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: 10/06/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Female