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

Catalog Number VS-402

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

Patient Problems Itching Sensation (1943); Pain (1994); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

Event date: date of article publication severe phlebitis-like abnormal reaction following great saphenous vein cyanoacrylate closure journal of vascular surgery: venous and lymphatic disorders (2019) 1-5 10.1016/j.Jvsv.2019.03.010.If information is provided in the future, a supplemental report will be issued.

Event Description

Case report on a patient who presented with complaints of bilateral lower extremity heaviness, pain, and swelling.Patient had previously undergone rfa of the left gsv with stab phlebectomy of varicosities 4 years prior for a healed venous ulceration.Patient had bilateral lower extremity pitting edema with class c3 venous disease on the right and c5 on the left.Venous ablation was recommended for management of her symptoms.Intervention was planned on the right leg first because that side was more symptomatic for the patient.The venaseal closure system was used for closure of the right gsv.The cyanoacrylate adhesive was primed into the 5f delivery catheter and this catheter/syringe combination was attached to the dispenser gun.This was then introduced through the 7f sheath and positioned 5 cm caudal to the sfj under ultrasound guidance.Two initial aliquots (0.2 ml) are injected proximally with 3 minutes of compression.Then, 1 aliquot (0.1 ml) is injected every 3 cm moving distally with 30 seconds of compression along the entire course of the gsv.After the last injection and compression sequence, the catheter and introducer sheath were pulled out of the site.The puncture site was closed with steri-strips.The total length of gsv treated was 50 cm using 1 ml of cyanoacrylate.Ultrasound examination confirmed closure of the treated gsv with no deep vein thrombosis at the sfj.Patient returned for follow-up 5 days post procedure ambulating with no difficulty and had minimal pain at the site of venous ablation.An ultrasound examination done during this visit confirmed successful closure of the vein with no evidence of deep vein thrombosis.6 days post procedure the patient presented back to clinic with worsening pain, erythema, and itching at the medial thigh.On examination, mild erythema was observed over the gsv.An ultrasound examination was repeated and was unchanged.Patient was diagnosed with phlebitis and was sent home on nonsteroidal anti-inflammatory drugs (nsaid) for symptomatic relief.A trial of compression therapy was attempted for symptomatic relief, but the patient reported increasing pain with that modality.8 days post-procedure the patient presented to the emergency department with severe worsening pain, erythema, itching, and swelling in the medial thigh and was unable to ambulate.Fever or chills were not present.White blood cell count was reported as 7500 cells/ml.Patient was admitted to the hospital for concern of a severe phlebitis-like allergic reaction to the cyanoacrylate.Patient was started on methylprednisolone orally and diphenhydramine (benadryl) and symptoms improved.Patient was discharged home after 2 days to continue steroid and antihistamine therapy for a total of 10 days.Patient was seen in clinic 12 days following venaseal treatment and was doing better.Erythema and swelling had decreased markedly, although continued complaint of pain and difficulty ambulating.18 days post procedure patient again presented to the emergency department with relapse of symptoms.Patient had completed prescribed therapy the day before this.Patient was restarted on steroid therapy and was scheduled to follow up in clinic.20 days post procedure, patient had follow-up appointment with improvement of symptoms.Steroids were discontinued after a few days and follow-up 1-month post-procedure showed near resolution of her erythema and swelling.

• 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: 8644143
• MDR Text Key: 146213748
• Report Number: 9612164-2019-01979
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 65 YR