MAUDE Adverse Event Report: MEDTRONIC INC., 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 Thrombosis (2100); Thrombus (2101)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that physician used a vena seal adhesive kit to treat a bilateral great saphenous vein (gsv) insufficiency.The device was prepped as per the ifu.The procedure was completed without incident.When patient was brought back for scan 4 days post procedure, the physician saw thrombosis in the common femoral junction.The patient was sent for further analysis to the radiology department and it was confirmed the patient had a dvt.The physician prescribed apixaban.Six weeks post-diagnosis of the dvt, the patient presented again and he was reported to be doing well.The patient demonstrated no symptoms of a dvt.However, the physician has advised that the patient complete a 3 month course of apixaban.

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): MEDTRONIC INC.,; parkmore business park west; parkmore; galway,gw
• Manufacturer (Section G): MEDTRONIC INC.,; parkmore business park west; parkmore; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7682066
• MDR Text Key: 113788358
• Report Number: 9612164-2018-01708
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

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: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• 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: 69 YR