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

Catalog Number	VS-404
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a venaseal procedure was performed for venous insufficiency involving the bilateral great saphenous veins and b ilateral small saphenous veins.Two venaseal kits were used during the procedure.There were no challenges or deviations related to location of catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to spj.Compression of ssv was utilized.At an approximately 72-hour ultrasound follow-up, a non-occlusive thrombus extension from the right small saphenous vein into the popliteal vein was identified and was reported as egit 3 with an extension of approximately 4.78 cm, and there was uncertainty whether the finding represented glue extension or thrombus.The ultrasound technologist stated they did not think the finding was glue extension.The physician reported a concern that something was wrong with the delivery gun and that it delivered more glue than intended.Anticoagulation therapy was initiated and the patient was prescribed eliquis.At a subsequent ultrasound and physician visit approximately one week later, the thrombus extension into the popliteal vein was reported to have regressed to approximately 4.41 cm and remained egit 3, and anticoagulation therapy was continued.At another ultrasound and physician visit approximately one week later, the thrombus extension into the popliteal vein was reported to have regressed to approximately 1.1 cm and was reported as egit 2.Anticoagulation therapy was continued with an additional follow-up planned.During a follow up ultrasound on (b)(6) 2026, the ssv was closed prox to mid calf with thrombus 2.6 mm from the junction.There was a thin rim of chronic thrombus along the anterior wall of the 8.7 mm into the popliteal vein.After discussion with ultrasound techs and physician, this was not a glue extension as previously reported, but a classic thrombus extension.Patient discontinued elliquis, was asymptomatic and no follow up needed.The issue was resolved on (b)(6) 2026.
Additional Manufacturer Narrative
D6a: date is approximate.Month and year are confirmed valid.Continuation of d10: implant date (b)(6) 2026; explant date n/a 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.

• 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: 25732525
• Report Number: 9612164-2026-03460
• Device Sequence Number: 13400427
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: (01)00763000240776(17)271031(10)84385
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/07/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VS-404
• Device Lot Number: 84385
• 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: 06/15/2026
• Initial Report FDA Received Date: 07/07/2026
• Date Device Manufactured: 10/31/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRODUCT ID VS-404 (84418), PRODUCT TYPE: ,
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 108 KG