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

Device Problem Biocompatibility (2886)

Patient Problems Ecchymosis (1818); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Discoloration (2074); Thrombosis/Thrombus (4440)

Event Date 07/13/2021

Event Type  Injury  

Event Description

A journal article was submitted detailing a study on the procedural efficacy for low-grade primary superficial venous reflux focusing on symptom characteristics and improvement patterns in the population 279 patient¿s had been treated with either cyanoacrylate ablation (ca) with ultrasound-guided foam sclerotherapy (ugfs) or endovenous laser ablation (evla) with ugfs.Medtronic¿s venaseal closure system was used for ca treatment in compliance with its instructions for use.All the patients were followed up at 1 day, 7 days, 1 month, and 3 months.The mean procedure time was significantly shorter in the ca with ugfs group.Delayed phlebectomy was implemented for 9.2% of the limbs within 3 months after surgery.At least one additional ugfs or sclerotherapy was performed for all the limbs (100%).The symptoms that showed the greatest improvement after treatment were night cramping (94.7%) and itching (93.8%), followed by heaviness (85.2%) and numbness (77.8%).The improvement in pain symptoms was similar in the two groups.Compared with the preoperative scores, the postoperative vross, vcss, civiq-14 score, and patient-reported symptom severity score were significantly improved.In the ca with ugfs group, two cases of grade ii endovenous glue-induced thrombosis occurred in the common femoral vein were reported.One of the two patients was treated with a 4-week duration of daily aspirin.The other patient was observed without any further treatment.Type iv hypersensitivity was noted in 24 of 87 patients (27.6%).Of these 24 patients, 15 required only oral antihistamine agents.Additional steroids were prescribed for the other nine patients.The hypersensitivity lesions were limited to the skin overlying the treated saphenous vein in 19 patients.Generalized skin allergic lesions were noted in the other five patients.Intradermal steroid injections along the treated vein were performed for three patients.They reported dramatically improved symptoms after the injection.In one patient, the type iv hypersensitivity lasted 15 months with tolerable symptoms.All other lesions were alleviated by medication within 35 days.Minor complications included transient hyperpigmentation, ecchymosis, and pruritus causing skin rash, erythema.

Manufacturer Narrative

Title: symptom improvement after cyanoacrylate glue adhesion and endovenous laser ablation in low-grade ceap clinical classes author: kilsoo yie journal: journal of vascular surgery: venous and lymphatic disorders year: 2021 vol/issue: 10(2) ref: 10.1016/j.Jvsv.2021.07.002 a2: average age.Majority gender :date of publication.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
• 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: 13636401
• MDR Text Key: 288601775
• Report Number: 9612164-2022-00833
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/01/2022

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: 03/01/2022
• 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: Female