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

Catalog Number VS-404

Device Problem Biocompatibility (2886)

Patient Problems Abscess (1690); Erythema (1840); Granuloma (1876)

Event Date 11/28/2023

Event Type  Injury  

Event Description

Physician used a venaseal closure system to treat a patient¿s great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Tumescent infiltration was not utilized.Local a nesthesia was used.No compression was used.No problems were noted during procedure.1 segment was treated and the vein was reported to have closed.It is reported 4 days post procedure, patient developed erythema that was proximal to the insertion site.This waxed and waned.Patient was put on courses of antibiotics and steroids however symptoms continued to recur.The patient presented to the clinic with an abscess and purulent fluid (b)(6) 2023).Abscess areas and granuloma with extruding glue casts were reported (b)(6) 2024.The area did not involve the insertion site.

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.

Manufacturer Narrative

Additional information: exact volume of glue is unknown.Method of glue carried out, back 1cm, glue back 3cm (compression) followed by glue, back 3cm for the remainder of the leg.Treatment was carried out on 19th oct 2023 with venaseal gun.Initial symptoms reported were aching, heaviness, fatigue, cramps, throbbing and pain.There is continuous swelling and patient has three areas in her lower leg where glue has extravagated outside the gsv.Patient feels pain along the gsv in the upper leg and is being referred to vascular surgeon for consult on how to remove the glue with endovascular vein harvesting.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.

Manufacturer Narrative

Image review one film image was returned for review.Review of image shows a single ultrasound with two images side by side.They are labeled left gsv medial prox calf.There appears to be a vein, likely the gsv, which is either occluded or partially occluded with thrombus or glue.There is no way to establish whether this is occluded without color flow and live video.¿ medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional information: patient has seen two different vascular surgeons who have recommended compression therapy until june.Patient has deep system swelling on us, which is why patient is in compression.It sounds like the patient has not had any more drainage from the abscess or glue extrusion, but the whole gsv feels like a rope according to the patient.Both surgeons would remove the gsv if not feeling better by june.Patient is seeing our surgeon, dr.(b)(6), on april 17th to advise next move.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional information: the area where the abscess was has hemosiderin stain over it but the abscess itself appears resolved at this time.Distally there is erythema along the gsv with some swelling.The erythema and swelling come and go.Patient no longer has the abscess or glue extrusion from the proximal calf.Physician doesn't believe she will completely improve until the glue distal to the abscess site has been removed.The patient has a follow up appointment in june with endovascular.Physician has recommended that she pursue the vein harvesting/removal of the distal gsv.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18669038
• MDR Text Key: 334951399
• Report Number: 9612164-2024-00667
• 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,Followup,Followup,Followup,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-404
• Device Lot Number: 70602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 12/20/2022
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 59 KG