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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)

Event Date 04/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal as per ifu for treatment of the patient¿s great saphenous vein (gsv) and short saphenous vein (ssv).A guidewire was used for insertion of the catheter.There was no deviations or problems in the procedure.The procedure was successfully completed without issue.The patient returned for a follow-up appointment one month later and vascular occlusion was confirmed without any symptoms or issues.The patient returned approximately one month later with symptoms of fever, redness and pain at the treatment site.The patient was admitted to another hospital.One month later it is reported the symptoms remain; fever is still present, and the patient was taking prescription antibiotics.The patient has also reported leg pain.Bactericide was only administered for about 3 days and was not currently available.C-reactive protein (crp) was currently decreasing.Currently the antibiotics are not being taken, but there is not worsening of suspected infection symptoms was found.Swelling and pain in the thighs of both legs have not disappeared.Steroids are ongoing.Crp value is still high at 10, but there was no fever.Thigh pain and swelling were subsided, an d steroids will be continuously administered, and the amount will be reduced.A patch test was requested to determine the patient¿s symptoms are directly related to the venaseal product.The result of the patch test was negative (potentially inaccurate due to steroid medication).Various infection routes were investigated for another month, but no findings were found.Although no clear confirmation has been made yet, another infection route and the cause of the event were examined, but the cause was not found.At this time, the most likely cause was venaseal.No further injury reported.

Manufacturer Narrative

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
• MDR Report Key: 11736760
• MDR Text Key: 247674355
• Report Number: 9612164-2021-01696
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention