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

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Phlebitis (2004); Skin Discoloration (2074); Numbness (2415); Thrombosis/Thrombus (4440)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to compare the clinical outcomes of cyanoacrylate closure (cac) with the venaseal system and surgical stripping (ss) for the treatment of incompetent great saphenous veins.126 patients were included in the study, of which 63 were in the cac group.Medtronic¿s venaseal system was used for treatment in the cac group.All types of anesthesia, including general, spinal, regional block, and local anesthesia, were used, depending on the patient¿s condition or preference.After successful access of the target vein and insertion of the guidewire, a delivery catheter was advanced to the saphenofemoral junction and positioned 5.0 cm caudally to the junction.With proximal gsv compression by the ultrasound probe, two injections of w0.10 ml of cyanoacrylate glue were administered 1 cm apart at this location, followed by a 3-minute period of local compression, with injections and 30-second ultrasound probe and manual compression sequences repeated until the entire length of the target vein segment had been treated.Target vein occlusion was confirmed using duplex ultrasound.The mean volume of injected glue for the cac procedure was 1.0 6 0.3 ml.Adjunctive procedures were performed simultaneously.Concomitant phlebectomy was performed at the operator¿s discretion and in accordance with patient desire.Concomitant phlebectomy was performed in 60.3% of the patients undergoing the cac procedure.Compression stockings were used for all patients for 1 week postoperatively.The patients wore the stockings during the day only.The closure rate of the target vein was 100% in both groups at 3 months postoperatively.Also, no patient had developed recurrence or recanalization at 12 months.Nine complications occurred in the cac group.All the complications in the cac group were minor.Endovenous glue-induced thrombosis (egit) developed in two patients.Both were egit grade i and did not require anticoagulation.A complex hypersensitivity and irritation reaction (chair), a unique complication after cac, occurred in three patients.All three patients with chair were treated with nonsteroidal anti-inflammatory drugs and antihistamine medication.The diagnosis of chair excludes simple phlebitic pain without an allergic or a hypersensitivity reaction, and such minor complications were, therefore, not evaluated in the present study.Numbness, tightness, and pigmentation along the glue-injected segment developed in one patient.In one patient, thrombosis distal to the treated segment occurred.However, this complication did not cause any symptoms or progress without anticoagulation.

Manufacturer Narrative

Title: a multicenter randomized controlled trial of cyanoacrylate closure and surgical stripping for incompetent great saphenous veins author: joh j.H., lee t., byun s.J., journal: journal of vascular surgery.Venous and lymphatic disorders year: 2021 vol/issue: s2213-333x(21)00422-4 ref: 10.1016/j.Jvsv.2021.08.012.A2: average age; a3: majority gender; b3: date of publication.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.

Manufacturer Narrative

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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12583329
• MDR Text Key: 274948755
• Report Number: 9612164-2021-03847
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• 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: 01/31/2022
• 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: 61 YR
• Patient Sex: Female