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

Model Number VS-402

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

Patient Problem Thrombus (2101)

Event Date 11/28/2016

Event Type  Injury  

Event Description

It was reported that the physician used the venaseal to treat the great saphenous vein in the right leg 5cm caudal of sfj.It was reported that instructions outlined within the ifu were followed with no issue noted.It was reported the patient had symptomatic pain in her right leg.An ultrasound approx.2 1/2 weeks post procedure showed 1.5cm thrombus in right common femoral vein.The patient was treated with eliquis 10mg and discharged.

Manufacturer Narrative

Investigation summary: an ultrasound exam report was provided.The report indicated a 10 mm to 13 mm of focus echogenic material extending from the greater saphenous vein into the patent common femoral vein.Per the exam report, there is no deep venous thrombosis and glue is present in the greater saphenous vein.The customer experience of the patent experience pain in the treated right leg was confirmed based on the provided ultra sound report.Thrombus or glue was extending from the greater saphenous vein into the common femoral vein.Md concluded no deep venous thrombosis and glue is present in the greater saphenous vein.The customer experience of thrombosis formation could not be positively confirmed.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.

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 LLC; 951 aviation parkway; morrisville NC 27560 6228
• Manufacturer (Section G): COVIDIEN LLC; 951 aviation parkway; morrisville NC 27560 6228
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6185809
• MDR Text Key: 62742404
• Report Number: 2183870-2016-00732
• 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,Followup
• Report Date: 03/27/2017

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 Expiration Date: 10/30/2017
• Device Model Number: VS-402
• Device Lot Number: 42355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided; 03/27/2017; 03/27/2017
• Supplement Dates FDA Received: 04/25/2017; 09/28/2017; 10/02/2017
• Date Device Manufactured: 10/08/2015
• 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: 80 YR