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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Granuloma (1876); Pain (1994); Ulceration (2116)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal to treat the patient¿s great saphenous vein (gsv).Ifu was followed and no issues are reported during the procedure.It is reported that 3-month post procedure the patient presented an ulcer on the ankle area of the treated leg with granuloma with extrusion of n-bca.The patient reported pain at points in skin where the adhesive was trying to come out of the skin.The physician manually removed n-bca and intralesional solu-medrol injections were given to patient.Also, silver alginate dressing was used.The patient¿s ulcer is reported to have healed and adhesive has been removed.The physician has reported that it is suspected the vein is still closed/dead and patient is doing fine.No further injury reported.

Manufacturer Narrative

Image review: four photographic images were received to medtronic investigation lab for evaluation.The first image is of the patient¿s lower right leg with a black sock at the ankle.The leg looks health but with a slight redness to the skin tone.The second image is of the patient¿s lower right leg.Five ulcers are visible along the treated vessel.The uppermost ulcer near the knee appears to be oozing.There is skin discoloration along the length of the treated vessel.The third image is of the patient¿s lower right leg and is a close-up of the previous image.The skin exhibits witness marks from a wound compression bandage.The fourth image is of extracted adhesive removed from the ulcer.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.

Manufacturer Narrative

The patient was originally given petrolatum dressing and prednisone pack (1 week 5 day course) however this treatment protocol was not working, so physician switched the treatment to silver alginate dressing and solu-medrol injections (40ml).Swelling has gone down.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
• MDR Report Key: 10127699
• MDR Text Key: 194304021
• Report Number: 9612164-2020-02132
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2020

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 06/08/2020; 06/18/2020
• Supplement Dates FDA Received: 06/09/2020; 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR