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 Stroke/CVA (1770); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Title: thrombotic complications of superficial endovenous ablation: a contemporary review of thermal and non-thermal techniques author: mariya s.Kochubey, sammy s.Siada, megan tenet journal: the journal of cardiovascular surgery year: 2021 vol/issue: 62(5) ref: 10.23736/s0021-9509.21.11898-1.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a case report of a stroke after cyanoacrylate ablation of the great saphenous vein.The patient was referred to the vascular clinic for a right lower extremity chronic wound present for several months.On exam, the right leg demonstrated a 0.5 cm2 medial malleolar ulcer.Patient underwent a comprehensive vascular examination which revealed a normal pulse exam of the lower extremities with normal abi¿s bilaterally.A physiologic venous ultrasound demonstrated reflux >0.5 seconds in the right great saphenous vein (gsv) from the saphenofemoral junction to below the knee, with a maximum diameter of 7.49 mm.There was no evidence of deep venous thrombosis or reflux, and the small saphenous vein and medial calf perforators were competent.The patient¿s venous stasis ulcer was initially treated with local wound care and compression and while the wound showed gradual improvement, failed to achieve complete healing and patient continued to have intractable lower leg cramping and swelling.After discussion with the patient about treatment options, the patient underwent great saphenous vein ablation with the venaseal¿ closure system.Venous ultrasound obtained within seventy-two hours after the procedure was negative for deep venous thrombosis (dvt) and demonstrated the thrombus 3 cm from the sfj in a longitudinal view.A month later however, the patient developed worsening edema in the right lower extremity and subsequent symptoms of right arm and leg weakness, prompting the patient to seek evaluation at the emergency department, where a left occipital infarct was identified on ct and mri.Right lower extremity venous ultrasound demonstrated a right common femoral vein thrombus.Carotid duplex was negative for significant carotid stenosis.A bubble echocardiogram revealed a patent foramen ovale.The patient was placed on therapeutic anticoagulation and demonstrated clinical resolution of the stroke symptoms.Given the clinical scenario, it was deduced that this patient¿s ischemic infarct was likely a result of an embolus from his deep venous thrombosis that developed despite a negative post-procedure duplex.This patient became symptomatic with leg swelling 4 weeks post ablation, highlighting a rare but life-threatening complication of non-thermal superficial venous ablation.

• 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: 13617193
• MDR Text Key: 286237454
• Report Number: 9612164-2022-00807
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2022

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
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male