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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Phlebitis (2004); Thrombosis (2100); Patient Problem/Medical Problem (2688)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

Journal article title: endovenous cyanoacrylate glue to treat varicose veins and chronic venous insufficiency¿experience gained from our first 100þ truncal venous ablations in a multi-ethnic asian population using the medtronic venasealtm closure system phlebology 0(0) 1¿9 the author(s) 2019 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/0268355519826008 jo urnals.Sagepub.Com/home/phl.If information is provided in the future, a supplemental report will be issued.

Event Description

Introduction: the aim of this paper is to report our experience with the device, looking specifically at safety, technical success, short-term efficacy (one year) and patient satisfaction of endovenous cag to target incompetent great saphenous vein (gsv), small saphenous vein (ssv) and/or anterior accessory thigh vein (atv) to treat varicose veins and cvi.This single-centre prospective study aimed to investigate the performance of vscs and document procedural tips learnt during treatment of our first 100þ legs.This is a unique real life registry of all new-comers from a multi-racial asian population with varying severity of venous disease.With a more liberal approach to inclusion, multiple incompetent truncal veins were treated at the same sitting with concomitant phlebectomies performed if deemed necessary.Methods and materials: a set protocol was constructed and adhered to in order to evaluate endovenous cag with the patented single use, disposable vscs.This was a single-centre, single arm, single-investigator study with a cohort of patients with symptomatic venous reflux disease in the gsv, ssv and/or accessory saphenous veins.Patients were excluded from having this procedure if they were pregnant, lactating, allergic or had a previous hypersensitivity reaction to cyanoacrylate, peripheral arterial disease (ankle-brachial pressure index 0.8), acute venous thrombo-embolism or sepsis, history of hypercoagulability and if their gsv/ssv were severely tortuous.Recurrent varicose veins, previous superficial thrombophlebitis (not active), which had recanalized and were incompetent and patients on anticoagulation with warfarin were not specifically excluded.Methods: a set protocol was constructed and adhered to in order to evaluate endovenous cag with the patented single use, disposable venaseal closure system (vscs).This was a single-centre, single arm, single-investigator study with a cohort of patients with symptomatic venous reflux disease in the gsv (great saphenous vein), ssv (short saphenous vein) and/or accessory saphenous veins.The primary outcome measures were as follows: technical success is defined as the ability to perform the procedure as planned and achieve immediate occlusion after the ablation.Anatomical success is defined as the occlusion of the treated truncal vein(s).Recurrence or treatment failure was defined arbitrarily as a re-opening of a continuous segment >5 cm in length with reflux present.The secondary outcomes included complications, patient satisfaction and post-operative pain using a visual analog scale (vas).Results: this study included 77 patients of whom 41 (53.3%) were females.The mean age was 57.9 14.5 years.All were diagnosed with either unilateral or bilateral symptomatic gsv/ssv incompetence or a combination of unilateral gsv and ssv/atv incompetence.Figure 1 shows the distribution and combination of truncal veins ablated.There were 103 truncal veins treated in 93 legs.In addition, 28/77 (36.4%) patients had concomitant phlebectomies.There were 43 (55.8%) chinese, 25 (32.5%) malay, 5 (6.5%) indian, 2 (2.6%) caucasian and 2 (2.6%) filipino in terms of ethnicity.There were no device-related complications, and the venasealtm catheter was delivered without incident to the intended position in the truncal vein in all cases (100% technical success).No major adverse events were observed, i.E.Pulmonary embolism, transient ischaemic attack, migraines, nerve injury, skin necrosis, infection or pigmentation except for one case of clot found in the left external iliac vein in a bilateral gsv treated patient.The patient was asymptomatic in terms of leg swelling at two-week follow-up and was prescribed a three-month course of rivoroxaban.A follow-up ultrasound at three months showed that the external iliac vein was patent and the clot had resolved.Transient superficial phlebitis was reported in 10/93 (10.8%) legs.Which were all self-limiting and had resolved with anti-inflammatories by three months.Transient mild or moderate ecchymosis from the puncture site was reported in 8/93 legs (8.6%).Only 2/93 (2.2%) were moderate in nature, and all had resolved by three months.No major adverse events were observed, i.E.Pulmonary embolism, transient ischaemic attack, migraines, nerve injury, skin necrosis, infection or pigmentation except for one case of clot found in the left external iliac vein in a bilateral gsv treated patient.The proximal gsv in the thigh was noted to be large at 12 mm.This clot was likely some spill over from the sfj as the gsv was completely occluded.The patient was asymptomatic in terms of leg swelling at two-week follow-up and was prescribed a three-month course of rivoroxaban (xareltotm, bayer ag, nj, usa).A follow-up ultrasound at three months showed that the external iliac vein was patent and the clot had resolved.Transient superficial phlebitis was reported in 10/93 (10.8%) legs.Nine cases came from those who had a unilateral or bilateral gsv procedure, 1 case from a combined gsv/ssv ablation ¿ the phlebitis developing along the line of the above knee gsv.Most of the phlebitis was noted along the line of the treated ak-gsv rather than its tributaries.In all cases, this was mild and self-limiting.At three-month followup, these cases had fully resolved.Transient mild or moderate ecchymosis from the puncture site was reported in 8/93 legs (8.6%).Only 2/93 (2.2%) were moderate in nature, and all had resolved by three months.The complication rate (as defined by phlebitis, cellulitis and skin pigmentation ¿ all transient) per patient had no significant association (p ¼ 0.168) between unilateral (5/51, 9.8%) and bilateral or combined gsv/ssv (6/26, 23.1%).There was no increased risk of developing thrombophlebitis post-ablation if you were female (male 12.2% (6/49) vs.Female 7.4% (4/54), p ¼ 0.512, odds ratio (or): 1.74, 95% confidence interval (ci): 0.46¿6.59) and whether the gsv went supra-fascially (yes: 6.8% (3/44) vs.No: 11.9% (7/59) in developing thrombophlebitis (p ¼ 0.510, or: 0.54, 95% ci: 0.13¿2.23).Also, 9/10 (90%) complications were phlebitis, which were all self-limiting and had resolved with anti inflammmatories by three months.No patients required steroids.Discussion: limitations of the study include the fact that this is a single-centre series with a limited incomplete follow-up period (12 months), albeit relatively large, multi-racial and mostly asian.Furthermore, this cohort reflects a more advanced group of cvi patients and real-life all comers.Collection of data was both prospective and retrospective in nature, which may have biased some of the outcomes measured.Randomized trials with a prolonged follow-up protocol are clearly indicated to compare closure rates directly with other endovenous modalities, especially as most recanalizations are seen to occur during the second and third years after treatment conclusion: cyanoacrylate glue (cag) is a safe and efficacious modality to ablate the great and short saphenous veins in asian patients in the short-term (one year).The procedure can be safely expanded to bilateral procedures and multiple truncal veins in the same leg, which are well tolerated.There is a high satisfaction rate and peri-procedural pain is low.Early results are promising, but further evaluation and longer term follow-up are required in the form of randomized controlled and cost-effectiveness studies.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8386261
• MDR Text Key: 137699577
• Report Number: 9612164-2019-00754
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• 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: 02/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR