MAUDE Adverse Event Report: MEDTRONIC IRELAND 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 Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal closure system to treat the great saphenous vein (gsv), 28cm segment treated.Approximately 0.6-0.8ml of adhesive was used.It was reported that the vein closed, and the procedure was completed per the ifu.The lumen was flushed prior to use and ifu was followed during, preparation, procedure and post- procedure.It was reported that 48 hours post procedure, scan showed grade two thrombus extension.The patient has been described eliquis and is reported to be stable.

Manufacturer Narrative

Image review: four photographs of sonographic images were received for evaluation.Image 1 is an annotated longitudinal scan in the area of the saphenofemoral junction, (sfj).The locations of the sfj and the adhesive (¿glue¿) are annotated on the scan.Image 2 is a cropped enlargement of image 2.Due to the quality and clarity of the image it is not possible to positively determine if thrombus is present or not.Image 3 is a transverse, (cross section), scan of the sfj.A reflective mass in the great saphenous vein is visible.Due to the quality and clarity of the image the reflective mass may or may not be thrombus.Image 4 is an annotated longitudinal scan just proximal of the sfj.A reflective mass in the great saphenous vein is visible.Due to the quality and clarity of the image the reflective mass may or may not be thrombus.Image 5 is a transverse, scan of the sfj.A reflective mass is visible in the great saphenous vein between the two computer colored renderings.Due to the quality and clarity of the image the reflective mass may or may not be thrombus.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: 8854657
• MDR Text Key: 153072437
• Report Number: 9612164-2019-03202
• 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
• Report Date: 10/09/2019

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 10/09/2019
• 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