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 Pain (1994); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: average age.Sex: majority gender.Date of event: date article accepted.Journal article title: clinical features and management of ¿¿phlebitis-like abnormal reaction¿¿ after cyanoacrylate closure for the treatment of incompetent saphenous veins annals of vascular surgery park et al.Ann vasc surg 2019; 55: 239¿245.Https://doi.Org/10.1016/j.Avsg.2018.07.040 2018.Elsevier inc.All rights reserved.If information is provided in the future, a supplemental report will be issued.

Event Description

The objective of this study is to investigate the clinical features of phlebitis-like abnormal reaction (plar) which is the most common adverse event after cyanoacrylate closure (cac); and to report its management.Plar occurring after cac is similar to conventional phlebitis but differs in appearance and occurs more frequently than the phlebitis occurring after endothermal ablation.In this study it was defined as any unusual suddenly appearing skin condition such as erythema, itching, swelling, and pain/tenderness over the treated vein area several days after the cac.This prospective observational study included 160 patients with 271 incompetent saphenous veins underwent cac with the venaseal system.A total of 201 great saphenous veins (gsvs) and 70 small saphenous veins (ssvs) were treated.In early medical management of plar in this study patients were administered only oral nonsteroidal antiinflammatory drugs (nsaids) for 5e14 days to prevent plar.Later, we added oral antihistamine for 10e14 days and intravenous dexamethasone to prevent plar.Of the entire 271 treated veins, 69 experienced plar (25.4%).The mean time of occurrence was 13.6 ± 4.6 days after the procedure.The analysis of accompanying symptoms in the 69 saphenous veins that experienced plar showed that the occurrence of erythema, itching, swelling, and pain/tenderness was 92.2%, 91.2%, 66.2%, and 48.5%, respectively.In addition, hives occurred in 4 patients during the study period, all of whom had no history of allergies.Hives developed 1 to 3 days after plar in treated areas, and in two of the cases, it involved the upper trunk and scalp areas.An unusual finding was noted with respect to plar.In most cases, plar occurred bilaterally in patients in whom the gsv was treated in both the legs.There were no significant differences in the incidence of plar between the different medication regimens.Groups were split into the following: nsaids alone for 5 or 14 days, nsaids and antihistamine for 10 days, and nsaids and antihistamines for 10 days, followed by intravenous dexamethasone immediately before therapy, which we designated as groups n5, n14, na10, and dna10, respectively.Nsaids and antihistamines have also been administered to patients for a period of 14 days.Moreover, in cases where itching and tenderness are severe, steroid ointment is applied and appears to ameliorate symptoms.

• 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: 8373496
• MDR Text Key: 137245566
• Report Number: 9612164-2019-00710
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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
• Date Manufacturer Received: 02/13/2019
• 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: 44 YR