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

Catalog Number VS-404

Device Problem Biocompatibility (2886)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

Image analysis the image is of the patient's leg.A bandage dressing has been pulled down to reveal what appears to be two open wounds and areas of dark discoloration, surrounded by red, swollen and flaking skin.The reported patient event can be confirmed.There is no indication from the images attached that the vena seal device caused the reaction on the patients leg.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.

Event Description

A patient presented to pinnacle vein and vascular clinic with venaseal reaction from procedure done at an outside facility (united vein center).This was the patient's 4th vein treatment in total, and the only treatment/vein with a reaction.The short saphenous vein (ssv) vein was treated.Patient was seen by the physician who performed procedure and antibiotics were prescribed for alleged infection and referred to wound clinic.Patient was then in hospital post treatment for treatment of cellulitis.Patient presented to physician regarding a patient reaction from an outside facility that was seen in their office.The reaction was seen near the access point.Patient has extreme redness, swelling, flaking skin and skin burrowing in two areas, as well as pus drainage and open wound.The patient was prescribed a medrol dos pack and nsaids.Explant of vein is scheduled.

• 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: 15813062
• MDR Text Key: 303797696
• Report Number: 9612164-2022-04287
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• 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): Other
• Patient Sex: Female