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

Device Problem Biocompatibility (2886)

Patient Problems Granuloma (1876); Swelling/ Edema (4577)

Event Date 06/05/2020

Event Type  Injury  

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.

Event Description

Patient reported in the summers of 2020 & 2021 i had numerous venaseal procedures done to close veins in both legs.I was told by the surgeon that before he could help me with one varicose vein that i wanted removed, he needed to do the venaseal procedures, and i believed him.After the procedures in the summer of 2020, i returned for a follow-up ultrasound in the spring of 2021 after i knew all bills had been paid from the summer of 2020.I had already paid (b)(6) to the surgeon and was not willing to incur any other debt, at (b)(6) per venaseal treatment, until i was sure all procedures had been paid.It took my insurance company until (b)(6) 2021 to pay bills from (b)(6) 2020.Last summer, after another ultrasound, the surgeon told me i needed more venaseal procedures and again, intrusted him.At my follow-up appointments, i told the surgeon my left leg was swollen, and he told me it would go away and left the room.At another visit, i told him i can feel a pea-sized piece of plastic in my left upper thigh and again his response was that it will go away and left the room.At the last visit where i tried to get help from the surgeon, i told him again about the swelling in my left leg and he pointed to a venaseal poster in the room which promotes having venaseal procedures done if you have leg swelling.It does nothing to address swelling in your leg after venaseal.The surgeon's response, if questioned or challenged, is to be defensive and dismissive.I did find out when i requested my records, that on each of these visits, the surgeon said that i had no issues or complaints.I again waited for my insurance company to cover each(b)(6) procedure and it took them until this past month to finally pay the last visit of (b)(6) 2021.Again, i waited so as not to incur any more expense because of the (b)(6) that i did not have and had to give to the surgeon.I have waited for 1 year for the swelling in my left leg, and now my foot, and the pea-sized piece of plastic in my right thigh to go away.They have not.I think i have waited long enough.I asked if there was any chance of getting any of my money back to try & find someone who can help me.That request was never addressed by the surgeon's office.I was offered the chance to make another appointment to see him and i refused, telling the woman in his office that i do not trust him, and he wouldn't help me when i asked for help.I am so sad and angry because all i wanted was for a 2" long varicose vein by my right knee to be removed and now, i have all of these health issues.I never had pain or swelling or any such issues with my legs before venaseal and now i have more spider/varicose veins than i ever had, a plastic lump in my thigh, some swelling in my right leg and major swelling in my lower left leg into my foot.The bottom of my left foot has numbness and pain with the swelling.I get weird sensations in my legs that feel like something crawling in them.I assume this is the blood moving in veins that are now blocked.The inner part of both of my lower legs has dark spots and is sore to the touch.Because this is your product, is there anything y ou can do to help me - any suggestions? my pcp suggested a vascular surgeon and the woman at the original surgeon's office gave me the name of another vein center.I am afraid to try another vein center and am not sure what a vascular surgeon will suggest.I am an otherwise healthy woman and this whole mess has me so angry that i am reaching out to anyone i think can help me without another huge outlay of money.I just don't have it.I would appreciate any help that you can give me since venaseal is your product.

Manufacturer Narrative

Additional information reported that the patient still has a swollen left leg and foot that is now numb on the bottom from the middle of foot to toes.There is a pea-sized hard piece that can be felt in upper right thigh and swelling in that 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.

• 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: 15146079
• MDR Text Key: 297043576
• Report Number: 9612164-2022-02896
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/12/2022
• 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 Sex: Female