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

Catalog Number SP-101

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

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

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

Event date is literature article published date cyanoacrylate glue used to treat great saphenous reflux: measures of outcome phlebology (2017) 32(2) 99-106 10.1177/0268355516638200.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

The aim of this study was to measure the safety, efficacy, and performance of endovenous cyanoacrylate used for the treatment of the great saphenous vein (gsv).This study included 57 legs in 29 patients including primary varicose veins.The median age of the patients included in this study was 63 (range 39-80) with the population being predominantly female (20 f, 9 m).The median gsv diameter is reported as being 7.1mm (range 3.9-11.4mm) and the median treatment length 27cm (range 19-33cm).Mean procedure times was 64 minutes.All gsv¿s were punctured percutaneously, cannulated according to the protocol and all cyanoacrylate injections were at precisely 4cm from the sfj.The following operative complications were reported: two minimal extension of thrombus to the deep vein which required treatment of subcutaneous low molecular weight heparin injections for 1 week.Follow-up ultrasound revealed resolution of the dvt; one minor wound infection over an avulsion surgical site is also mentioned in the study which resolved with wound dressings, and one patient experienced mild paraesthesia over dorsum of the foot which improved upon follow-up.The mean follow-up period for this cohort of patients was 9 months (range 1-13 months).The following closure rates were reported: 1 week: 100%, 1 month: 95.3%, 6 months: 90.3%, 12 months: 78.5%.It is reported that there was no total recanalization.Partial recanalization occurred in 7 legs but none of these recanalized gsvs resulted in clinical recurrence.This study showed that the use of endovenous cyanoacrylate in the treatment of the gsv reflux was safe.It also showed that simultaneous treatment of bilateral incompetent gsv¿s can be performed using one bottle of cyanoacrylate making the procedure more cost effective.Analyses of recanalization showed that gsv¿s with > 8mm were more likely to exhibit recanalization on follow-up but did not determine the mechanism for this.All patients are reported to have had symptomatic improvement as shown by the vcss and avvq.

• 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: 6822254
• MDR Text Key: 83701122
• Report Number: 3011410703-2017-00343
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• 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: 63 YR