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 05/05/2017

Event Type  Injury  

Manufacturer Narrative

Average age.Majority gender.Event date is literature article published date recanalization with endovenous cyanoacrylate treatment j vasc interv radiol 2017, issue 28 doi: 10.1016/j.Jvir.2017.01.011.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

This clinical study aims to determine the predictors of recanalization for incompetent great saphenous veins (gsv) in patients treated with endovenous cyanoacrylate.This study included 55 patients (108 legs).The mean patient age reported is 65 years (range 39-86yrs) with 21 male and 34 female patients.The mean diameter of gsv which was treated was 6.6mm (with a range 2.3-11.4mm).Median treatment length was 28cm with the median procedural time reported as 64 minutes.All gsv¿s were punctured percutaneously with the exception of 2 which required open cut-down due to the small diameter.Of the 108 legs treated in this study, the following complications were reported: 2 cases of minimal extension of thrombus to deep vein which were treated with subcutaneous low-molecular-weight heparin injections for 1 week; 4 cases (legs) of thrombophlebitis, treated with a short course of oral nonsteroidal anti-inflammatory drugs and one minor wound infection was also reported which was treated with oral antibiotics and chlorhexidine).Kaplan-meier analysis showed gsv closure rates were 97.2%, 92.3%, 89.2%, and 75.7% at 1 week, 1 month, 6 months, and 12 months after the procedure.With a median follow-up period of 5 months (range, 0¿18 months), 4 legs had clinical recurrence.Mean gsv diameter of 6.6 mm was the only significant predictor for recanalization (hazard ratio 12.1; 95% ci, 1.6¿92.7; p ¼.016).In conclusion, it is reported that the use of endovenous cyanoacrylate to treat varicose veins caused by incompetent gsv was safe.Gsvs <(><<)> 6.6 mm in diameter had a closure rate of 90.0% at 12 months.Despite 97.2% closure rates at 1 week, recanalization was observed in gsvs with larger diameter.

• 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: 6822222
• MDR Text Key: 83699766
• Report Number: 3011410703-2017-00342
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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

• 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
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/25/2017
• 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: 65 YR