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); Injury (2348)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had a venaseal procedure to treat the left gsv (great saphenous vein).It was reported the vein closed.Follow up study was done six days post procedure, an ultra sound showed the glue was 6 cm from the (superficial femoral artery) and there was a clot extending from the end of the glue to 2 cm into cfv (common femoral vein).No patient injury reported.

Manufacturer Narrative

Additional information: the catheter tip was measured and placed 5cm caudal to the saphenous femoral junction prior to initial delivery of adhesive.Patient was prescribed eliquis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the clot extension has resolved.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: a disc containing sonographic images was received and reviewed.The first two sonograms received were of the patient¿s left gsv.The third sonogram shows a slight amount of sonographic reflective response on the right side of the vessel.Other sonograms show a sonographic reflective response is noted in the centre of the vessel.This reflective response is further studied in the other sonograms provided.The amount of reflective response is an indicator of possible thrombosis formation in the vessel.The remaining sonograms show a reduction in the sonographic reflective response associated with thrombosis in the vessel.The reduction is consistent with the reported event that at a follow-up examination after eight days of pharmaceutical treatment with eliquis that the clot extension had been reduced.The clot extension is now reported to be resolved.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: 8974206
• MDR Text Key: 156880425
• Report Number: 9612164-2019-03798
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 20643169986262
• UDI-Public: 20643169986262
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 54557
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: VS-402
• Device Lot Number: 54557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2020
• Date Device Manufactured: 02/07/2019
• 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): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73