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

Model Number VS-404

Device Problem Biocompatibility (2886)

Patient Problems Fever (1858); Chills (2191)

Event Date 04/23/2022

Event Type  Injury  

Event Description

Patient received venaseal treatment to the right great saphenous vein (gsv), 56cm of vein was treated.The procedure was completed as per ifu without any issues.The vein is reported to have closed.Patient had undergone venaseal treatment of the left gsv 5 months prior with no issues noted.The patient returned for a follow-up appointment following treatment of the right gsv 11 days post implant.The patient reported having fevers and chills since within 48 hours of the procedure.The patient had a temperature of 101f and went to see primary care physician.The patient was evaluated and the procedure site was unremarkable.No findings on physical exam, urinalysis was obtained, cbc, all of which were negative.Patient was empirically started on a course of augmentin.Patient has reported since then having fever and chills in the afternoon after lunch.No other associated symptoms: no myalgias or athralgias, no headache, no visual changes, and no joint pain.Patient will take tylenol and symptoms improve.Patient has also been tested for covid recently and was negative.No associated rashes at the procedure site.Patient's appetite has been good and patient has not been feeling extremely sick.The patient has reported getting tired and aches with fevers.The patient's procedure site and leg are unre markable.There is no erythema or tenderness on leg and no rashes are present.No further patient injury reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient had an aortic valve placed 12 years ago and has history of fibromyalgia.Symptoms started 24 to 36 hours after treatment.Patient was treated with the course of sagema metro and resolved within 24 to 36 hours.Symptoms have completely resolved.Crp was elevated, rate was elevated at 41 with normal being 35.Blood culture white count remained negative.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: 14285666
• MDR Text Key: 290774652
• Report Number: 9612164-2022-01666
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: 00763000240776
• 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,Followup
• Report Date: 05/25/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: VS-404
• Device Catalogue Number: VS-404
• Device Lot Number: 65285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/25/2022
• Date Device Manufactured: 10/11/2021
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 93 KG