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	Arrhythmia (1721); Dyspnea (1816); Erythema (1840); Fever (1858); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Itching Sensation (1943); Nausea (1970); Local Reaction (2035); Chills (2191)
Date of Event	02/14/2025
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
Medtronic patient services received a call about a systemic allergic reaction that occurred after a venaseal procedure.Patient had 2 venaseal implants on (b)(6) 2025 & (b)(6) 2025.The onset of symptoms was a couple of days after her first procedure.Both small saphenous veins (ssv) were treated and reaction was present in both.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 sfj.Compression was utilized.The vascular surgeon chose to repeat usage of n-butyl cyanoacrylate after he realized (from first exposure) the patient was allergic to cyanoacrylate which caused and continues to cause a daily severe systemic allergic reaction that has lasted 44 days so far.The patient shakes, is feverish, experiences chills, low blood pressure, full body or partial body itching (hives), red inflamed skin, palpitations, shortness of breath, nausea, head and face are hot and feel flush every day.Concomitant medical products and other treatments include 81mg aspirin, restassis, rosuvastatin, & vesicare.A medral dose pack was prescribed and according to the physician the itching had largely disappeared.
Additional Manufacturer Narrative
Additional information: vascular surgeon used venaseal (n-butyl cyanoacrylate) glue to close varicose veins that caused a type iv hypersensitivity issue and caused mast cell activation syndrome.Almost 3 months later still experiencing severe issues and mast cell flares and will experience issues for about 5 years because of this glue product.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: vascular surgeon used venaseal a second time after noting the patient had an allergic reaction to the glue causing a systemic allergic reaction with symptoms that include heart palpitations, tremors, full body hives now chronic hives to present day, high blood pressure levels, dizzy, nauseous, unsteady, fainting, slurred speech, headache, very fuzzy and memory impairment, diarrhea, shortness of breath, etc.The n-butyl cyanoacrylate may have triggered mast cell syndrome; patient waiting to see allergist/immunologist again.The patient is unable to eat anything with soy, sulphites, nitrates, any high histamine foods or full body hives result.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: 22068272
• Report Number: 9612164-2025-02535
• Device Sequence Number: 8703192
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: (01)00763000240776(17)260831(10)78775
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: VS-404
• Device Lot Number: 78775
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 10/07/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/19/2025; 10/31/2025
• Date Device Manufactured: 08/14/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 113 KG