MAUDE Adverse Event Report: MEDTRONIC IRELAND 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 02/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician used venaseal to treat 25cm of a patient¿s great saphenous vein (gsv).The ifu was followed and hand compression was used.The vein successfully closed and no issues were reported during the procedure.The post op scan was normal.During a follow up scan, a thrombus extension was present and anti-coagulant therapy (xarelto) was administered to the patient to successfully eliminate and resolve the thrombus.

Manufacturer Narrative

There were no challenges or deviation related to the location of the catheter tip prior to delivery of adhesive.The catheter was positioned 5cm caudal to the sapheno femoral junction (sfj) and compression was used as per standard procedure guidelines.The patient had no symptoms.Condition resolved on (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: three images were received.Image 1 shows a terminal valve in an sfj and a patent segment of vein in a cross section/transverse view.Image 2 shows a thrombus extension into the cfv (kabnick class 3).Image 3 shows a spj (saphenous-popliteal junction) that appears normal for the most part.The customer experience of a patient treated with venaseal developing a thrombosis level 3 extension in the area of the saphenofemoral junction post procedure scan was confirmed.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): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8390464
• MDR Text Key: 137827482
• Report Number: 9612164-2019-00777
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/04/2019

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 Model Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 03/07/2019; 05/28/2019; 05/31/2019
• Supplement Dates FDA Received: 03/25/2019; 05/29/2019; 06/04/2019
• 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