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

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Neuropathy (1983); Pain (1994); Phlebitis (2004); Skin Discoloration (2074); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Event date: date of article publication, month and year valid nonthermal endovenous procedures for varicose veins: a health technology assessment ontario health technology assessment series (2021) 4;21(8):1-188.If information is provided in the future, a supplemental report will be issued.

Event Description

A health technology assessment series literature conducted by ontario health was received providing an overview of how safe, effective, and cost-effective nonthermal endovenous procedures are for people with symptomatic varicose veins.It also looked at the budget impact of publicly funding thermal and nonthermal endovenous procedures and at the experiences, preferences, and values of people with varicose veins.A systematic economic literature search and cost-utility analysis with a 5-year time horizon were performed.The study assessed the cost-effectiveness of nonthermal endovenous procedures (cac and mechanochemical ablation (moca)) compared with surgical vein stripping and thermal endovenous therapies (evla and rfa).The literature concludes that major complications of any procedure were rare, with minor complications occurring as expected and resolving.Medtronic¿s venaseal closure system is referenced in the article as part of the review of cac treatments.The article states that to 5% of people receiving the procedure may experience hypersensitivity or allergic or foreign body reactions.Severe hypersensitivity reactions tend to be very rare (<(><<)> 0.5%), with most cases that do occur being mild and self-limited.During systematic review of literature detailing cac procedures versus other therapies available, medtronic¿s venaseal closure system was amongst the products assessed for vein closure as compared with rfa treatment.The trial found gsv closure after cac to be noninferior at all follow-up time points through 5 years.Vein closure tended to be slightly better in the cac group compared with rfa across studies and time points.Cac closure was also compared with evla through review of three studies, where it was reported that vein closure (total occlusion) was similar between cac and evla across studies and time points with a potential trend toward better closure with cac was seen in one study.One randomised control trial (rct), and one non-randomised study which compared cac with multiple alternative treatments found no statistically significant difference between the groups.One additional study which compared outcomes of a population with extremely dilated veins was included which found that the cac group had a lower proportion of closed veins.Recovery time from cac procedures as compared with alternative treatments found that patient¿s in who had received cac treatments required less days off work.The paper reports that people¿s overall quality of life after cac improved from baseline, and responses from patient satisfaction were positive.Complications reported after cac from the literature reviewed included pain, phlebitis-like reaction, phlebitis, superficial thrombophlebitis, cellulite, stocking irritation, ecchymosis, hyperpigmentation, and paresthesia, sensitivity, induration, edema, sural neuropathy.One case of dvt is reported as a major complication in one of the studies assessed which was clinically asymptomatic and treated with a course of anticoagulant.Access site issues recorded included subcutaneous infection and a painful lump at site due to foreign body response.All lumps were removed under local anaesthetic.No one became systemically ill, 1 person was also put on antibiotics, and all healed without issue.One patient reported being pleased with the cac treatment but indicated having an allergic reaction to the glue post implant.The author concluded that moca and cac treatments for people with symptomatic varicose veins were found to be similarly effective at achieving improvements in clinical symptoms and quality of life compared with thermal endovenous procedures.Complication profiles differed between nonthermal endovenous procedures, thermal ablation, and surgical vein stripping.Major complications were reportedly very rare and minor complications occurred at similar, low frequencies across intervention groups.

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: 12251367
• MDR Text Key: 264265355
• Report Number: 9612164-2021-02956
• 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: 08/05/2021

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
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention