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); Itching Sensation (1943); Rash (2033)
Date of Event	07/01/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a patient experienced a  hypersensitivity reaction to venaseal treatment.Within 24 hours of treatment, the patient developed hives and a rash along the treated vein, with hives spreading over the body.The reaction was recurrent, with symptoms including itching and rash flare-ups.The patient was treated with two rounds of steroids, which initially helped, but the symptoms persisted.Despite seeing a dermatologist, there was no improvement, and the patient was advised to consult an allergist.The hypersensitivity reaction was associated with the treatment of the great saphenous vein and short saphenous vein on the right side.The issue remains unresolved, patient continues to have hives which do have occasional flare ups with itching.Patient denies having a previous allergy to adhesives and latex.
Additional Manufacturer Narrative
Additional information: the patient was initially treated at another practice (center for vein restoration) and our customer does not have specific details on the exact dates of treatment or dosage of treatment.The physician has reported that the patient has a has a complicated venous history of allergic reaction to venaseal in (b)(6) 2024 at cvr.Following this the patient developed swelling and hives all over her body.Patient was seen at the urgent care as there was no physician available hcvrna put on a dose of steroids and omnicef.Patient has got somewhat better but continued to be symptomatic and again went back to cvr but they were unable to treat her and told her they did not give steroids and she went back to drs.Care who gave her another round of steroids.Since that time she intermittently has episodes of hives.Patient cannot clearly identify what triggers these reactions and is also complaining of continual discomfort in the right leg.Patient is to follow up with again on 3/13.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: the patient follow up with the physician in march after having seen an allergist.Patient was started on new allergy medications as well as xolair injections and symptoms have improved.Patient also had sclerotherapy done at the end of march and hasn¿t had any reactions so far.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: 21374287
• Report Number: 9612164-2025-00772
• Device Sequence Number: 3597063
• Product Code: PJQ
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/03/2025

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 Catalogue Number: VS-404
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 04/23/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/13/2025; 05/04/2025
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 51 KG