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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Nerve Damage (1979); Phlebitis (2004); Thrombosis/Thrombus (4440)

Event Date 01/01/2021

Event Type  Injury  

Event Description

We conducted a retrospective observational single-center study detailing outcomes for all patients with symptomatic lower limb chronic venous insufficiency treated with saphenous vein closure with cyanoacrylate ablation (venaseal) between january 2016 and december 2020.All patients were reviewed at 6-weeks post-operatively and outcomes recorded.We identified 235 patients matching our study criteria.The majority were new zealand european followed by maori and pacific.The most common indication was venous ulceration.Other indications included superficial thrombophlebitis, recurrent cellulitis, lower limb venous bleeding and deep vein thrombosis.Fifty percent underwent bilateral treatment.Only one saphenous vein (gsv or ssv) required treatment in 88% of patients.The most common post procedure symptom was phlebitis in 49 patients which is an expected part of recovery.Excluding phlebitis, only 33 complications were noted, all being relatively minor.We report 15 cases of residual varicose veins, 9 saphenous nerve neuropraxia cases, 6 cases of wound cellulitis and 3 dvts.We concluded the safety and efficacy of venaseal ablation for symptomatic saphenous vein incompetence.Complications were minor and rate of re-operation was 6% (for residual varicosities).We require on-going follow up to establish long term outcomes.

Manufacturer Narrative

Title: 5-year venaseal outcomes for symptomatic saphenous incompetence:is this the clear choice? author: morwan bahi journal: annals of vascular diseases year: 2021 vol/issue: 14(167) ref: sex: majority gender date of event: date of publication 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: 15101176
• MDR Text Key: 296570332
• Report Number: 9612164-2022-02804
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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?: Yes
• Date Manufacturer Received: 06/27/2022
• 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): Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: Native Hawaiian Or Other Pacific Islander