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

Catalog Number	VS-404
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033); Local Reaction (2035)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis #(b)(4): three images were provided for evaluation.The patient is covered in a rash.The reported event can be confirmed from the image provided.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that following a procedure involving the venaseal, the patient experienced a clinical reaction characterized by a rash that developed outside the treatment area, specifically not in the axial artery or vein.Only one leg was treated and the reaction was on that leg.The onset of symptoms occurred between days 2 and 14 after the procedure, and this was the initial reaction event.The issue was still present at the time of reporting.Additional information received 04 march 2026 medical intervention was required, and the patient was treated with a prescription steroid (medtrol dose pack) but symptoms persisted.The affected locationwas the peripheral vein(s), including the great saphenous vein, with involvement noted in proximal, mid, and distal segments.No challenges or deviations related to the location of catheter tip prior to initial delivery of adhesive, the catheter tip was 5 cm caudal to sfj and compression of gsv was applied.Symptoms did not resolve and the vein was removed on 2/12 and the patient is reported to be ok now.No patient complications have been reported as a result of this event.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Common Device Name: 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: 24712866
• Report Number: 9612164-2026-01569
• Device Sequence Number: 12194187
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: (01)00763000240776(17)270831(10)83295
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VS-404
• Device Lot Number: 83295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 08/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female