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

Catalog Number UNK-PLY-VENASEAL

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

Patient Problems Unspecified Infection (1930); Thrombus (2101); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Age at event: average age.Sex: majority gender.Doi: 10.1177/0268355518794105.Comparison of cyanoacrylate embolization and radiofrequency ablation for the treatment of varicose veins.If information is provided in the future, a supplemental report will be issued.

Event Description

Objective: to review clinical outcomes of varicose vein patients treated with cyanoacrylate embolization and radiofrequency ablation at our institution.Event description: a study of venaseal to treat the gsv was performed with 335 patients between january 2014 and december 2016, a review of clinical outcomes of varicose vein patients treated with cyanoacrylate.Patients presented post procedure with superficial phlebitis, paresthesia, dvt from glue migration surgically removed and treated with antibiotics, delayed wound healing at the access site required outpatient debridement and continued wound care.These wounds eventually healed up at the six weeks follow-up.Methods: a retrospective review of patients who underwent cyanoacrylate embolization and radiofrequency ablation during a three-year period.Patient records were reviewed to assess demographics, location and severity of disease, treatment details and outcome at short- and mid-term follow-ups.Outcome parameters included treatment success and complications.Results: between january 2014 and december 2016, 335 patients with 476 veins were treated with either cyanoacrylate embolization (n=148) or radiofrequency ablation (n=328) at the (b)(6) general hospital vascular surgery vein clinic.The average age of patients were 57±1 years with the majority being female (78%) and an average bmi of 24.8±0.5.Ceap classes were 2 (49%), 3 (26%), 4a (22%) and >4b (3%).Of the veins treated with cyanoacrylate embolization, the vein types were as follows: 76% were great saphenous vein, 16% were small saphenous vein, 5% were anterior accessory great saphenous vein and 1.4% were perforator veins.The vein types for radiofrequency ablation were 88%, 9%, 3% and 0%, respectively.The average amount of cyanoacrylate embolization delivered for great saphenous vein treatment was 1.8±0.1ml with a treatment length of 43±1cm.Subgroup comparison was done for great saphenous vein segments.Treatment success was 100% in cyanoacrylate embolization and 99% in radiofrequency ablation.Superficial phlebitis was the most common complication noted at mid-term follow-up in 5% of cyanoacrylate embolization and 16% of radiofrequency ablation treatments (p < 0.05).One patient in each group had asymptomatic proximal thrombus extension treated with anticoagulation for 2¿3 weeks.Three superficial infections from glue clumps were noted in the cyanoacrylate embolization group requiring excision and drainage.Five patients in the radiofrequency ablation group had persistent numbness and one wound complications at the access site.Conclusion: cyanoacrylate embolization offers equivalent success rates with lower mid-term complication rates as radiofrequency ablation.

• 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: 8706786
• MDR Text Key: 148275274
• Report Number: 9612164-2019-02384
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2019

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
• Device Catalogue Number: UNK-PLY-VENASEAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/18/2019
• 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: 57 YR
• Patient Weight: 73