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

Catalog Number VS-403

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

Patient Problems Pain (1994); Phlebitis (2004); Local Reaction (2035); Swelling/ Edema (4577)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

Literature title clinical features and management of ¿¿phlebitis-like abnormal reaction¿¿ after cyanoacrylate closure for the treatment of incompetent saphenous veins ann vasc surg 2019; 55: 239¿245 https://doi.Org/10.1016/j.Avsg.2018.07.040 a2 majority gender a3 average age b3 date of pulication.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Background: cyanoacrylate closure for the treatment of incompetent saphenous veins does not cause thermal damage and demonstrates sa tisfactory outcomes with rapid recovery.However, the characteristics of phlebitis-like abnormal reaction (plar), the most common adverse event after cyanoacrylate closure, have not been clarified.Moreover, it differs from typical phlebitis after thermal ablation.The objective of our study is to investigate the clinical features of plar after cyanoacrylate closure and to report its management.Methods: a total of (b)(4) patients with (b)(4) incompetent saphenous veins (great saphenous veins, (b)(4); small saphenous veins, (b)(4)) underwent cyanoacrylate closure with the venaseal system.We defined plar as any unusual skin condition that develops suddenly, such as erythema, itching, swelling, and pain/tenderness, over the treated veins several days after cyanoacrylate closure.Oral antihistamines and intravenous dexamethasone were administered to manage plar.Results: of the (b)(4) treated veins, (b)(4) experienced plar (25.4%).The mean time of occurrence was (b)(4) days after treatment.The rate of occurrence of erythema, itching, swelling, and pain/tenderness were (b)(4), respectively.The occurrence of plar was significantly higher for great saphenous veins than for small saphenous veins (p <(><<)> 0.001).Occurrences were more frequent in cases with a suprafascial great saphenous vein of length >10 cm than in cases with a subfascial great saphenous vein (p ¼ 0.001).The proportion of patients who reported swelling decreased by more than half after the administration of oral antihistamine.The pain score on the 10th day also decreased significa ntly after the administration of antihistamine (p ¼ 0.006).Conclusions: plar must be distinguished from classic phlebitis.We believe that plar is a type iv hypersensitivity reaction due to a foreign body, and in our experience, antihistamines or steroids are eff ective for the prevention and management of plar.

• Brand Name: VENASEAL 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: 18355880
• MDR Text Key: 330885009
• Report Number: 9612164-2023-06063
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-403
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• 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: 45 YR
• Patient Sex: Female