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

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Granuloma (1876); Itching Sensation (1943); Phlebitis (2004); Thrombosis/Thrombus (4440)

Event Date 01/01/2024

Event Type  Injury  

Event Description

Medtronic received a literature article titled 'allergic contact dermatitis to venaseal: a sticky situation'.A 59-year-old woman presented with rash after varicose vein treatment.In (b)(6) 2022, she underwent left great saphenous vein ablation with venaseal.Within 3¿4 days of the procedure, she developed pruritus and erythematous patches on the medial aspect of the left lower extremity extending from the midthigh to distal lower leg.Symptoms persisted despite multiple courses of oral and intravenous antibiotics for suspected infection.Owing to her lack of improvement, she underwent surgical excision of areas affected with presumed infectious superficial thrombophlebitis.There was purulent appearing material observed around the vein that was cultured and washed out.She was placed on sulfamethoxazole/ trimethoprim empirically; however, wound and blood cultures were negative.The patient¿s symptoms persisted and, therefore, she underwent re-exploration of the surgical site.Small tributaries of the great saphenous vein were found to contain materials suspected by the surgeon to be venaseal, and she underwent resection of these tributaries.Pathology analysis from the tissue showed an inflammatory infiltrate composed of neutrophils, eosinophils, lymphocytes, and scattered plasma cells as well as necrotizing granulomatous inflammation suggestive of changes related to the venaseal procedure.Grocott-go¨mo¨ri¿s methenamine silver stain and acid-fast bacteria stains were negative.A prednisone taper was initiated, which significantly improved her symptoms.However, for the year post-venaseal she continued to intermittently develop cyst-like papules on the left leg that when excised revealed small black pellets.Patient underwent patch testing with ethyl cyanoacrylate as well as a sample of venaseal ¿¿as is.¿¿ at 72 hours she had a 1+ reaction to ethyl cyanoacrylate 10% petrolatum and a 2+ reaction to venaseal.

Manufacturer Narrative

Ref: doi: 10.1089/derm.2023.0183.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 18827508
• MDR Text Key: 336863739
• Report Number: 9612164-2024-01068
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• 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