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

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Pain (1994); Phlebitis (2004); Thrombosis/Thrombus (4440)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Title: multicentre randomised clinical trial comparing mechanochemical ablation versus cyanoacrylate adhesive for the treatment of primary truncal saphenous veins incompetence: mocca study author: a belramman, r bootun , ty tang, tra lane, ah davies journal: avls annual congress year: 2021, average age, majority gender, average weight, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received details of a presentation related to a multicentre randomized clinical trial comparing mechanochemical ablation (moca) versus cyanoacrylate adhesive (cae) for the treatment of primary truncal saphenous veins incompetence (mocca study) presented at the avls annual congress, october 2021.The primary outcome was pain score using a 100mm vas and 0¿10 number scale.Secondary outcomes were 10 days postoperative pain score, changes in clinical severity and quality of life scores, degree of ecchymosis, time to return to normal activities/work, time to stop wearing compression, and occlusion rates.128 patients (64 per group-cae and moca) were included in the study.No significant differences were noted in pain score in both groups.There were no significant differences in the degree of ecchymosis in the groups.Three cases of superficial thrombophlebitis and one case of thrombus extension were reported in the cae group.A similar improvement was reported in clinical and quality of life scores for the groups.

Manufacturer Narrative

Additional information: the full article for 'pain outcomes following mechanochemical ablation truncal saphenous vein incompetence the mocca randomized clinical trial' was received.The objective of the study was to assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs cyanoacrylate adhesive treatment.Patients with primary truncal vein incompetence were randomized to receive either mechanochemical ablation (moca) versus cyanoacrylate adhesive (cae).There were 167 study participants.Overall, 155 truncal veins treated (92.8%) were great saphenous veins.Four patients treated with cae and adjunctive procedures developed minor complications: 3 superficial thrombophlebitis and 1 thrombus extension (endovenous glueinduced thrombosis).One thrombophlebitis case was in a patient receiving extended vte prophylaxis postprocedure.Treatment was gsvcae ablation and foam sclerotherapy.Three months after the intervention, the patient presented with calf pain.Dus identified chronic occlusion of the t reated veins without dvt, and no treatment was required.The other 2 cases of superficial thrombophlebitis developed in patients treated for gsv incompetence and ambulatory phlebectomy.The superficial thrombophlebitis developed in the truncal vein and resolved without treatment.One thrombus extension to the level of the common femoral vein occurred (endovenous glue-induced thrombosis) in an elderly patient treated for gsv incompetence at 6 weeks.Although the patient was asymptomatic, he was treated with anticoagulation.Repeated dus confirmed no thrombus in the common femoral vein and the anticoagulation was stopped.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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13620783
• MDR Text Key: 290184666
• Report Number: 9612164-2022-00819
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 06/01/2022

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
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 06/01/2022
• 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): Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 76 KG