MAUDE Adverse Event Report: SAPHEON INC VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number UNK-PLY-VENASEAL

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Phlebitis (2004); Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: estimate of when events began journals.Sagepub.Com/home/vas https://www.Ncbi.Nlm.Nih.Gov/pubmed/27206470.

Event Description

A study was conducted to evaluate the cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression using venaseal closure system.This is a post-market evaluation of the venaseal system (the waves study).50 patients with an average age of (b)(6) and a history of chronic venous insufficiency were treated with the venaseal closure system in the gsv, ssv, and asv.Ten patients presented post procedure with phlebitis, treated with acetaminophen or non-steroidal anti-inflammatory agents, the condition was resolved completely by one month, hives treated with an antihistamines oral steroid.One patient had thrombus extension protruding 2mm into the saphenofemoral junction at the seven-day duplex ultrasound (dus).This patient was not treated, was asymptomatic and the thrombus extension was no longer evident at the 1 month dus study.Other adverse events included gastroenteritis, allergic reaction and local access site reaction.

Manufacturer Narrative

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): SAPHEON INC; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer (Section G): SAPHEON INC; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6632510
• MDR Text Key: 77274085
• Report Number: 3011410703-2017-00242
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-PLY-VENASEAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 49 YR