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	Granuloma (1876); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an attempt was made to use a venaseal vs-404 to treat a soft tissue lesion in the left proximal mid short saphenous vein (ssv).Patient had an adhesive plug.Patient had left ssv venaseal procedure on ((b)(6)).Patient started developing open wounds on the distal 1/3 of the leg around mid september and kept developing more and progressing higher to the popliteal junction region.Physician said they were unsure it was granuloma.Physician is not the one treating it, but a dermatologist.Dermatologist had treated the patient for antibiotics flucloxacillin for cellulitis.According to the dermatologist, pieces of hard substances kept coming out and the 3 swab biopsies performed also kept showing up with pseudomonas.Physician said if it did not have pseudomonas, physician would have left it alone and observed it.Since there was pseudomonas, they planned to excise and explant them, the ssv.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information: patient is doing much better/improving.Patient is almost fully recovered after the explant (vein was excised and all the adhesive removed on the (b)(6) 2025).Patient was given antibiotics after excision, but is off antibiotics at this time.Imageanalysis the customer returned two images for evaluation image 1: this image depicts a picture of a photograph on a phone.This image depicts the patient¿s leg, the left calf muscle is visible and a number of red raised areas can be seen along the length of the leg.Image 2: this image depicts a picture of a photograph on a phone.The screen photo is of what appears to be 6 pieces f a yellow type substance, from this image it is unclear as to what the substance may be.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: 24105429
• Report Number: 9612164-2026-00322
• Device Sequence Number: 10243860
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: (01)00763000240776(17)261031(10)79625
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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: 79625
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 02/09/2026
• Initial Report FDA Received Date: 01/17/2026
• Supplement Report FDA Received Date: 02/05/2026; 03/06/2026
• Date Device Manufactured: 10/07/2024
• 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; Other
• Patient Sex: Male