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 Pulmonary Embolism (1498); Cellulitis (1768); Erythema (1840); Hemorrhage/Bleeding (1888); Pain (1994); Phlebitis (2004); Local Reaction (2035); Transient Ischemic Attack (2109); Paresthesia (4421); Thrombosis/Thrombus (4440)

Event Date 02/01/2022

Event Type  Injury  

Event Description

A journal article was submitted detailing a retrospective study which aimed to demonstrate the relationship between healing active ulcers and ablation between different modalities of ablation.146 patients were included in the study.Patients were treated with venaseal, rfa, or evlt.The primary outcome was the time to ulcer healing.Secondary outcomes were the rate of recurrence, compliance with compression, and participation in a wound clinic.The study showed a non-significant difference in days to ulcer healing post-intervention between ablative techniques.A similar, non-significant trend was observed for ulcer recurrence, with a rate of 35.7% for venaseal 26.7% for evlt, and 23.1% for rfa.Few local and systemic complications occurred.The most common complication was dvt after procedure.The same non-significant trend occurred with dvt following procedure, being observed in 12.5% of patient¿s treated with venaseal, 9.5% in the evlt group and 6.5% in rfa cases.

Manufacturer Narrative

Title: longer healing times, higher recurrence rates, and increased incidence of dvt following cyanoacrylate ablation for active venous ulcerations author: lindsey korepta, matthew ward journal: annals of vascular surgery year: 2022 vol/issue: 79 ref: doi.Org/10.1016/j.Avsg.2021.12.057.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A2 age: mean age a3 sex: majority sex a5a ethnicity: majority ethnicity a5b race: majority race additional information: systemic complications included allergic reactions, deep venous thrombosis (dvt), pulmonary embolism (pe), transient ischemic attack (tia), stroke (cva), and death.There were no allergic reactions, pe, tia, or cva observed in the 1-year post-operative for this patient cohort.Leg specific complications were recorded during a follow-up period of 1- year, including bleeding, pain, blistering, erythema, paresthesia, superficial thrombophlebitis, cellulitis, endovascular heat induced thrombosis (ehit), endovenous glue induced thrombosis (egit), and ulcer recurrence.There were limited numbers of other minor local complications observed.Bleeding, pain, blistering, erythematous skin changes, paresthesia, superficial thrombophlebitis, and cellulitis were also nearly 0% across all groups.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: 13860517
• MDR Text Key: 287673495
• Report Number: 9612164-2022-01113
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

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?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 06/08/2022
• 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: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White