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

Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Phlebitis (2004); Thrombosis (2100); Ulcer (2274); Swelling/ Edema (4577)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

The purpose of the a singapore venaseal real world post-market evaluation study (asvs) is to evaluate the performance of cyanoacrylate closure (cac) for varicose veins in a prospective multi-racial asian population registry from singapore.We report early clinical and patient satisfaction outcomes at 3 months post intervention.The study evaluated the technical, anatomical and clinical performance of vscs performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the great saphenous vein (gsv), small saphenous vein (ssv) and/or anterior accessory saphenous vein (aasv).The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3, 6 and 12 months.100 patients (151 legs; 100 procedures, 59 females and mean age was 60.1± 12.7 years) underwent cac between april - december 2018.49 (32.5%) legs were treated for great saphenous vein (gsv) incompetence, 96/151 (63.6%) bilateral gsv, 1/151 (0.7%) small saphenous vein (ssv) and 5 (3.3%) combined unilateral gsv and ssv reflux.At baseline, 68/151 legs (45.0%) had c4-c6 disease and 67/151 (44.4%) legs had concomitant multiple stab avulsions.There was no deviation of the protocol.All gsv and ssv/atv were successfully punctured percutaneously.There were no device ¿related complications and the venaseal catheter was delivered without incident to the intended position in the truncal vein in all cases (100% technical success).During treatment, transducer 2cm cranial to 5cm to allow some spread of glue cranially during plunging but probe distal to iev to allow flow and minimise thrombus extension proximally.There were no challenges or deviations related to the location of catheter tip prior to initial delivery of adhesive.The most common ae was minor bruising (<(><<)> 25% of the treated area) in 45 (45%) patients and this was typically at the puncture site at the mid calf level.These all resolved by the 3-month review.Two patients had thrombus extension that protruded 5mm into the saphenofemoral junction at the 2-week duplex ultrasound visit.These patients, although asymptomatic, were treated as a dvt with anticoagulation, and the thrombus extension was no longer evident at the 3-month duplex ultrasound scan.Twenty seven patients developed phlebitis.Most of the phlebitis was noted along the line of the treated gsv rather than its tributaries and generally more widespread in the thigh.In all cases, this was mild and self-limiting.At three-months follow-up these cases had fully resolved.One patient developed total body hives within the first 2 weeks of the procedure, consistent with cyanoacrylate allergy, which improved after treatment with antihistamines and a short course of steroids.Patients were treated with self limiting, nsaids.

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

Additional information: additional information has been received for 6 months to one year follow up outcomes.One anatomical re-opening is reported at 6 months and four reported at 1 year, with only one requiring additional treatment.There were no further adjunctive procedures such as phlebectomies or foam sclerotherapy in the cohort.However, 4/90 (4.4%) 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 4 had advanced ceap stage (c4a = 4) at baseline.Median time to ivus and stenting was 190 days (iqr 177-241 days).All symptoms had resolved after this.The peak in improvement was at 3 months.There was no further improvement or change at the 6 and 12 months intervals, although the e ffect was relatively sustained.5 adverse events occurred in 4 subjects from 3 to 12 months all deemed mild (reported a phlebitis like reaction affecting their thigh region (all above the knee gsv ablation) at the 6 months interval and further one at the 12 month visit.All 4 patients described a sudden itching, pain, erythema and tenderness in their inner thigh along the line of their gsv, without any obvious precipitating factors.All events were self limiting and resolved with antihistamines and anti-inflammatories within 10 days.One patient required a one week course of oral steroids.A separate group of 8/90 (8.9%) patients complained of a pulling sensation during walking or exercise between the 3 and 12 months follow-up visits.Although the gsv was completely occluded on duplex, a distinct cord - the occluded fibrosed gsv was palpable below the skin, which was likely the cause of the symptom.These were noticed in the thinner patients with a bmi <(> <<)> 22 and majority were female.By 12 months, albeit mild in nature, none had fully resolved.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
• MDR Report Key: 9699128
• MDR Text Key: 182473244
• Report Number: 9612164-2020-00686
• 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,Followup
• Report Date: 02/03/2021

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
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/19/2020; 04/29/2020; 01/11/2021
• Supplement Dates FDA Received: 02/24/2020; 04/30/2020; 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR