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

Catalog Number SP-101

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

Patient Problems Inflammation (1932); Patient Problem/Medical Problem (2688)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

No components from the venaseal closure system kit was received for evaluation.No photographic images of the patient¿s symptoms were received for evaluation.Four photographic images of sonogram images were provided.The images show a possible thrombosis/adhesive mass protruding into the sapheno-femoral junction.Customer experience is confirmed based on photographs provided.

Event Description

It was reported that the patient received vena seal treatment of the left and right great saphenous vein (gsv).Procedure was completed as per ifu and standard protocols.Catheter tip was located 5cm caudal to the sapheno-femoral junction (sfj) prior to initial delivery of the adhesive.Volumes used were reported as 1.5cc in left gsv <(>&<)> 1.2cc in right gsv.The total lengths treated were reported as 38cm left gsv, 32cm in right gsv.It was reported that the vein closed.On ultrasound check, 2 days post procedure, it could be seen that the glue protruded past the sfj.It is reported that the patient was prescribed xarelto due to protrusion of the glue.The patient is reported to be doing well.Follow-up information indicates the patient had a mild inflammatory response, however follow-up ultrasound indicates that the protrusion has retracted distal to the sfj.The physician plans to continue with xarelto for a full course of 12 weeks.

• 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: 7180870
• MDR Text Key: 96929762
• Report Number: 9612164-2018-00051
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2018

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: SP-101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/10/2018
• 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: 54 YR
• Patient Weight: 81