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

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Rash (2033)

Event Date 09/02/2021

Event Type  Injury  

Event Description

A journal article was submitted presenting case reports of patients treated with venaseal.Clinical case 3 presents a patient with untreated long-term bilateral varicose veins who presented with pain of the left leg with severe interference to quality of life.The patient started medical treatment with nsaids, venotropic and topical corticosteroids associated with the use of elastic stockings with initial symptomatic improvement.Symptoms then recurred associated with the appearance of an ulcer on the leg at 30 days.The doppler ultrasonography showed bilateral insufficiency of the great saphenous vein with a diameter greater than 8 mm.It was proposed to perform, in an outpatient basis treatment, with venaseal of the left great saphenous vein associated with varicose veins foam sclerotherapy dus guided which was uneventful.In the second day an erythematous rash appeared on the face prompting systemic corticosteroid therapy.After a 2-month follow-up, the patient is asymptomatic with a healed ulcer, with the imaging control showing occlusion of the great saphenous trunk.

Manufacturer Narrative

Title: venaseal: a good solution in the treatment of severe superficial venous insufficiency in very elderly patients author: marta machado, miguel machado, arlindo matos journal: angiologia e cirurgia vascular year: 2021 vol/issue: 17(3) ref: 10.48750/acv.409.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: 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: 14050650
• MDR Text Key: 288851768
• Report Number: 9612164-2022-01369
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 97 YR
• Patient Sex: Female