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

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Phlebitis (2004); Swelling/ Edema (4577)

Event Date 07/08/2023

Event Type  Injury  

Manufacturer Narrative

Literature ref: https://doi.Org/10.3390/diagnostics13142 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.

Event Description

Medtronic received a journal article reporting ¿cyanoacrylate glue for treating chronic saphenous vein insufficiency: a retrospective observational single-center study¿.This retrospective single-center study searched our institutional database to identify patients who underwent endovenous cyanoacrylate ablation to treat great or small saphenous vein insufficiency at the dijon university hospital (dijon, france) between december 2018 and march 2021.55 patients with 67 treated veins were included.The same data were collected for the follow-up visits seven days then one, three, six, and 18 months after the procedure.At each visit, bruising at the access site was sought by physical examination and vein recanalization and deep vein thrombosis by ultrasound.All ultrasound scans and endovenous glue ablations were performed by the same physician (n.F.), who had six years of experience in endovenous cyanoacrylate ablation.All procedures were performed according to a rigorous standardized protocol, using the venaseal system, which injects aliquots of nbca along the vein.Local anaesthesia of the puncture site was the first step.The saphenous vein was punctured under the doppler ultrasound guidance, and a 7-fr introducer was inserted.A dilator was advanced over a guide to the saphenofemoral or saphenopopliteal junction, depending on the target vein.The dilator was then replaced by the device catheter, whose tip was placed 5 cm from the saphenofemoral junction or 3 cm for the saphenopopliteal junction.The first administration of the product consisted of a double injection (about 0.2 ml) followed by a local compression of the junction for 3 min.The second aliquot of 0.1 ml was delivered after pulling the catheter back 1 cm.After a 3-cm pullback, compression was applied to the vein for 3 min, using the ultrasound probe.The catheter was again withdrawn by 3 cm, and an aliquot of 0.1 ml was administered, followed by compression for 30s.This manoeuvre was repeated every 3 cm along the entire length of the vein, regardless of its length and the type of vein treated.However, the last aliquot was administered 3 cm from the catheter access site.The catheter was removed, and complete occlusion of the vein was verified by ultrasound scanning of the entire length of the vein and to rule out spillage of glue into the deep venous system.Manual compression was applied during the scan to check the absence of deep vein thrombosis.Additional phlebectomy under local anaesthesia or other additional procedures were performed as deemed necessary by the operator.After the procedure, patients were kept under observation in the postanesthesia care unit for approximatively 1 h to ensure the early detection of immediate complications such as access-site bleeding.Patients were prescribed grade 2 compression stockings and preventive-dose anticoagulation for the first week.The most common ceap class before the procedure was 3 (ankle edema due to varicose veins).The reasons for starting preventive anticoagulation at the time of the procedure were atrial fibrillation and a history of pulmonary embolism without diagnosed deep vein thrombosis.Venaseal was used out of current recommendations and off label in ceap class 1 in five patients.A total of 32 gsv and 35 ssv were treated.The mean size (mm) of the treated veins was 8.5± 2.4 (6¿16).Immediately post-procedure and at the 48h follow-up, all patients had complete occlusion of the treated vein segments as assessed by duplex ultrasound.The closure rates were 100% at one month, 98.5% at 6 months, and 97.0% at 12 months.At 18 months, the closure rate was 94.0% (95% confidence interval, 84.7¿98.0%).There were no life-threatening adverse events.No technical failures occurred.There were no major adverse events involving the target veins, and neither did any patient experience access site infection or substantial hematoma formation.No thromboembolic events (phlebitis or glue-induced thrombosis) were recorded throughout the 18-month follow-up.The only adverse event was a supposed type iv delayed hypersensitivity reaction to cyanoacrylate in one patient one week after the procedure.Erythema, pain, edema, and pruritus developed in the area of the target vein, suggesting phlebitis.An ultrasound scan found no evidence of thrombosis.Corticosteroid and antihistamine therapy were effective in ensuring rapid resolution of the symptoms.Allergology tests confirmed the diagnosis of hypersensitivity to nbca.Real type iv delayed hypersensitivity is supposed to be more difficult to control by medication than glue-induced chemical inflammation since allergen is still present inside the vein.In such case, to achieve symptoms reduction, the surgical removal of polymerized glue from the body may be necessary, but it was not needed here.

• 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: 17920231
• MDR Text Key: 325493666
• Report Number: 9612164-2023-04625
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• 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: 09/15/2023
• 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: 60 YR
• Patient Sex: Female