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 Problem Thrombus (2101)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Image review: two images were returned for evaluation.The 1st image appears to be dilated proximal segment of a gsv.The image does not clearly show thrombus given the quality.The 2nd image shows what appears to be non-occlusive thrombus at the saphenofemoral junction.The non-occlusive thrombus may have slightly extended into the common femoral vein.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.

Event Description

Physician use venaseal occluding device during procedure to treat 2 segments in the great saphenous vein and anterior accessory great saphenous vein (gsv and aagsv).Local anesthesia was used.The lumen was flushed prior to use.The ifu was followed during preparation, procedure and post procedure.A guide wire was used for the insertion of the catheter.The procedure was finished per ifu.It was reported that during the initial follow up scan 2 days post procedure clot/thrombus was noted.The area that was treated was reported to be very swollen and the patient was unable to bend the leg that was treated.Mild erythema and warmth to the right leg noted.The physician prescribed a prednisone dose pack, oral pills, for the patient's treatment.Patient on xarelto also.The patient's condition has been reported to have been resolved a week after and the follow up scan revealed no deep vein thrombus left.There was no further patient injury reported.

• 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: 9691579
• MDR Text Key: 182473603
• Report Number: 9612164-2020-00654
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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
• Date Manufacturer Received: 02/26/2020
• 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: 66 YR
• Patient Weight: 101