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

Catalog Number VS-403

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Itching Sensation (1943)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

A physician used a venaseal closure system during treatment of a patients dual saphenous vein.34cm of vein was treated.Tumescent i nfiltration was not utilized.Local anesthesia was utilized.No compression was used.The catheter lumen was not flushed prior to use.The ifu (instruction for use) was followed during catheter preparation, procedure, post-procedure.No anomalies in vessel articul ation were reported.A guidewire was during catheter insertion and placement.The veins are reported to have closed.Occlusion of both sides of the gsv was observed.Subsequently, an incompetent perforating branch occurred in the middle of the left thigh and the r eflux recurred in the left great saphenous vein in continuity with embolization of the great saphenous vein.It was reported that redness started around the 3rd postoperative day, and on the 5th day, it spread to the entire inner thigh.Pruritus in the lower limbs was localized during rest on holidays and pruritus spreads to the whole body when working.The itching improved with 25mg of prednisolone (psl), gradually reduced, and is currently controlled with 6mg of prednisolone (psl).High value due to drug-induced lymphocyte stimulation (dlst) test.

Manufacturer Narrative

Additional information: the reaction was present in both legs.There were no challenges or deviations related to location of catheter tip prior to initial delivery of adhesive and the catheter tip was 5cm caudal to sfj.The issue is still present, the reflux recurred in the left great saphenous vein in continuity with embolization of the great saphenous vein.There is embolus left in the treated area, a gap is created between the treated saphenous vein and the embolus, and reflux is occurring.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VENASEAL 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: 19172557
• MDR Text Key: 340919154
• Report Number: 9612164-2024-01970
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: VS-403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/21/2024
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 63 KG