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

Device Problem Biocompatibility (2886)

Patient Problems Granuloma (1876); Insufficient Information (4580)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Title: cyanoacrylate granuloma after cyanoacrylate closure of incompetent saphenous veins author: nuttawut sermsathanasawadi, kanin pruekprasert, khamin chinsakchai journal: dermatologic surgery year: 2021 vol/issue: 47(10) ref: 10.1097/dss.0000000000003183.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a retrospective observational study to evaluate the incidence, the risk factors for, and the management of cyanoacrylate granuloma (cag) after cac of incompetent saphenous veins in patients with chronic venous disease.126 veins from 101 patients were included in the study.Bilateral cac was performed in 25 patients.Medtronic¿s venaseal closure system was used.All patients had undergone duplex ultrasound scanning before saphenous vein ablation.Patients were treated per the manufacturer¿s instructions for use (ifu) for treatment of saphenous veins.Recapture of the delivery catheter before withdrawal was not performed in all patients.Occlusion of the saphenous vein was verified by ultrasound examination immediately after the procedure.Neither compression stockings nor compression bandages were applied in patients with ceap classification c2 (varicose vein).In patients with ceap c3-c6 , patients were asked to continue using compression stockings or compression bandages the same as they had been using them before surgery.Patients were instructed to ambulate frequently and to resume their normal activities at their own discretion.Patients were followed up at the hospital at 1 week, 1 month, 3 months, and 12 months after the procedure for clinical assessment.Duplex ultrasound evaluation was performed at 1 week, 1 month, and 12 months after cac.Complete closure of the saphenous vein after cac was defined as closure along the entire treated saphenous vein without a patent segment greater than 5 cm in length.Preprocedural and postprocedural venous clinical severity score (vcss) and complications were recorded by physicians at each visit.If cag occurred, the onset, duration of symptoms, and management were collected.The occlusion rate was 100%, 99.2%, and 97.8% at the 1-week, 1-month, and 1-year follow-up, respectively.Seven patients who had persistent venous symptoms from tributary varicosity were treated with foam sclerotherapy at 3 months after cac.Cyanoacrylate granuloma occurred in 3 of 101 patients, in 3 of 126 (2.3%) limbs, and in 3 of 126 (2.3%) treated saphenous veins.Patients with cag presented with granuloma and abscess at the puncture site at 3, 4, and 5 months after cac.All cag occurred after cac of gsv.All patients were treated with incision, drainage, and removal of the glue foreign body.All patients received amoxicillin and clavulanic acid 1 gram twice daily for 7 days.Pus cultures showed no growth for bacterial infection.No recurrent granuloma was observed during the study period.

• 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: 13617778
• MDR Text Key: 286228444
• Report Number: 9612164-2022-00811
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 02/28/2022

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: 02/01/2022
• Initial Date FDA Received: 02/28/2022
• 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: 64 YR
• Patient Sex: Female