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

Catalog Number VS-402

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

Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2016

Event Type  Injury  

Event Description

The physician used a venaseal closure system during procedure of the great saphenous vein and the small saphenous vein.Approximately 85cm between both vessels were treated.At the conclusion of the procedure, no issues were identified.It was reported that 4 days post procedure the patient had a follow up ultrasound where it was noted that the common femoral vein was partially occluded.Further information supplied found that prior to initial delivery of adhesive the catheter tip was located 5cm from the junction.Additionally, compression was not held for the entire 3 minutes at the junction.The physician is monitoring the patient and has prescribed blood thinners.

Manufacturer Narrative

Two videos were provided for review - video 1 appears to be from a pre-treatment period.The thrombus extension is not apparent in this video.Video 2 is a post-treatment period in which the thrombus extension is seen extending into the common femoral vein.By a crude measurement the thrombus occludes the cfv by 41%, which warrants treatment by anticoagulation.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.

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): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5694345
• MDR Text Key: 46376886
• Report Number: 3011410703-2016-00013
• 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: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Device Lot Number: 40495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• 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 Weight: 59