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

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Phlebitis (2004); Thrombus (2101); Numbness (2415); Patient Problem/Medical Problem (2688)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Event date is literature article published date comparison of cyanoacrylate (venaseal) and radiofrequency ablation for treatment of varicose veins in a canadian population journal of vascular surgery (2017) volume 66, number 3, e48 10.1016/j.Jvs.2017.05.058 if information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to compare clinical outcomes of cyanoacrylate (ca) and radiofrequency ablation (rfa) in the treatment of varicose veins.This involved the review of medical records (medical records were reviewed to assess patient demographics, location, and severity of disease, treatment details, and outcome at short- and midterm follow-up).Outcome parameters included treatment success and presence of short- and midterm complications.Of 355 patients with 476 venous segments treated with ca (n 148) or rfa (n 328) for varicose veins at (b)(6) clinic.Of the 148 segments treated with ca, the vein types were 112 great saphenous vein (gsv), 24 short saphenous vein, 2 accessory gsv, and 8 perforator veins.The average amount of ca delivered for gsv treatment was 1.8 +/- 0.1 ml, with a treatment length of 43 +/- 1cm.Superficial phlebitis was the most common complication noted at midterm follow-up in 5% of patients who received venaseal treatments.One patient in each group received anti-coagulation for 2 weeks for asymptomatic proximal thrombus extension.Three superficial glue protrusions were noted in the ca group requiring minor incision and drainage.

Manufacturer Narrative

Additional information provided from full article (see below): treatment success was 100% in cyanoacrylate embolization and 99% in radiofrequency ablation.Treatment success was noted at short- and mid-term follow-up in all ca patients.Paresthesia was noted in three ca patients but this was resolved by the mid-term follow-up.One patient in the ca group had level 4 closure with minor thrombus protrusion into the femoral vein that was treated with two weeks of subcutaneous heparin.This patient not develop any further complications.In the ca group, three cases of superficial infection at the entry site with underlying subcutaneous abscess were noted.These cases presented as persistent non-healing painful lump at the entry wound with fluid collection surrounding a foreign body under ultrasound examination.None of the patients were systemically ill.Patients underwent surgical exploration under local anaesthesia and in each case the nidus of the infection was revealed to be a clump of glue which was surgically removed.One patient was also placed on oral antibiotics for two weeks.These patients went on to heal without further problems after the drainage and glue clump removal.Abstract article provided previously: comparison of cyanoacrylate (venaseal) and radiofrequency ablation for treatment of varicose veins in a canadian population journal of vascular surgery (2017) volume 66, number 3, e48 10.1016/j.Jvs.2017.05.058 full article provided 24-aug-2018 -rf ablation device identified plus additional information: comparison of cyanoacrylate embolization and radiofrequency ablation for the treatment of varicose veins phlebology (2018) 0(0) 1¿6 10.1177/0268355518794105.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; ballybrit; galway,gw
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7234425
• MDR Text Key: 98832330
• Report Number: 9612164-2018-00187
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2018
• 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