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

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Phlebitis (2004); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

Title: one-year outcome using cyanoacrylate glue to ablate truncal vein incompetence: a singapore venaseal real-world post-market evaluation study (asvs) author: tjun y tang1; charyl jq yap; shereen xy soon journal: phlebology year: 2021 vol/issue: 0(0) ref: 10.1177/02683555211013678.Average age, majority gender, date of publication, majority of race.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted presenting a 12 months efficacy data from ¿a singapore venaseal real-world post-market evaluation study (asvs)¿, a prospective single-arm asian population registry aimed to evaluate cyanoacrylate glue (cag) closure of refluxing truncal veins.Medtronic¿s venaseal closure system was used during the procedure.Primary symptoms reported include swelling, heaviness, a pulling sensation during walking or exercise, and thrombophlebitis.All phl ebitis like events were self-limiting and resolved with antihistamines and anti-inflammatories within 10 days.One patient required a one-week course of oral steroids.Suprafascial extension of the gsv is also reported.Thrombus extension that protruded 5 mm into the saphenofemoral junction at the two-week duplex ultrasound visit is reported for 2 patients.These patient¿s were treated as a dvt with anticoagulation, and the thrombus extension had resolved at the three-month duplex ultrasound scan.There were no serious adverse events such as death, symptomatic deep vein thrombosis, pulmonary embolism and serious infections requiring the glued gsv segment to be excised.No device related complications are reported.Gsv and ssv occlusion rate of 100% at 2-week follow-up.Gsv occlusion is reported as 99.3%, and ssv closure reported as 100% at three months follow-up.At 6 months follow-up period 99.3% of truncal veins remained closed, and 99.8 % and 100% of gsv andssv respectively.12 month results reported 97.7% truncal vein occlusion and 96.4% and 100% for gsv and ssv respectively.One anatomical reopening reported at 6 months (gsv) and four at one year (gsv) reported, only one re-intervention was required.Four patients underwent subsequent deep vein interrogation with intravascular ultrasound (ivus) assessment and iliac vein stenting for non thrombotic iliac vein compression syndrome.All had worsening symptoms and swelling and one had developed a venous ulcer.All four had advanced ceap stage (c4a = 4) at baseline.Only two of four patients had evidence of deep venous reflux on their initial cvi duplex ultrasound.Median time to ivus and stenting was 190 days.All symptoms had resolved after this.

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.

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
• MDR Report Key: 12015180
• MDR Text Key: 256708131
• Report Number: 9612164-2021-02351
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR