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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Vasculitis (2004); Local Reaction (2035); Swelling/ Edema (4577)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Literature was reviewed regarding: the long-term recanalization rates and the need for adjunctive procedures following cyanoacrylate closure, specifically venaseal, for the treatment of incompetent great saphenous veins.This included a comparison of venaseal with other superficial venous therapies for chronic venous insufficiency, as well as a network meta-analysis to evaluate the efficacy of venaseal.The time frame of this study was: between may 2020 and december 2021.The following medtronic devices were used: the study specifically used the venaseal system for the closure of the great saphenous vein (gsv) and compared its outcomes with radiofrequency ablation (rfa).All patients had successful closure of the gsv.Sfj thrombosis or dvt was not observed in any patient postprocedure.Postprocedural skin reactions occurred in 9.1% of venaseal patients and 7.1% of rfa patients (p ¼ 0.73), which included significant pain, swelling, and thrombophlebitis.The percentage of patients who had postoperative uc or emergency department visits related to the procedure in the venaseal versus rfa group was 3.6% and 0%, respectively no further information was provided pertaining to medtronic products.
Additional Manufacturer Narrative
A2: average a3a: majority sex literature ref: 10.1016/j.Avsg.2023.09.088 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Common Device Name: 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: 20350591
• Report Number: 9612164-2024-04472
• Device Sequence Number: 6553678
• Product Code: PJQ
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female