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 Inflammation (1932); Pain (1994); Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had diagnostic bilateral ultrasound carried out.This revealed no evidence of deep vein thrombosis or deep venous insufficiency bilaterally.Pulsatile flow demonstrated throughout the bilateral lower extremity veins.Bilateral greater saphenous vein reflux present involving the saphenofemoral junction.Thrombophlebitis of the right distal calf perforator and adjacent varicosities that does not extend into the posterior tibial vein.Left small saphenous vein reflux present distally.Incompetent perforator vein present in the distal thigh bilaterally.Approximately 1 month post diagnostic ultrasound, the patient proceeded with left great saphenous vein (gsv) venaseal treatment with good result and negative follow up ultrasound.7 weeks post treatment of left gsv, the patient proceeded with treatment of right gsv.Ifu was followed.Catheter was 5.6 cm distal to the sapheno-femoral junction (sfj).2 aliquots delivered proximally, 1 aliquot for every 3 cm distally.A total of 55cm of vein was treated.Follow-up ultrasound carried out 3 days post treatment of right gsv showed non-occlusive acute deep vein thrombosis of the right popliteal vein.Patent right common femoral, profunda femoris and femoral veins.Successful closure of the right greater saphenous vein with no evidence of adhesive extension into the common femoral vein.Closure of the right mid-thigh incompetent perforator vein.Superficial thrombophlebitis of the mid-thigh tributary.It is believed the thrombus may possible been have from original superficial thrombophlebitis identified in diagnostic scan, but this has not been confirmed.Patient complained of mild pain and swelling in right lower extremity.The patient was prescribed eliquis to treat the superficial thrombophlebitis.Patient due to return for follow-up ultrasound.

Manufacturer Narrative

Additional information: patient had follow-up ultrasound carried out which revealed the proximal right popliteal vein is fully recanalized.Moderately recanalized right mid popliteal vein.The distal right popliteal vein shows minimal recanalization; however, the duplicated distal right popliteal vein is widely patent.No evidence of deep vein thrombosis of the right common femoral, profunda femoris and femoral veins.The right greater saphenous vein remains successfully sealed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: there is no further treatment planned for this patient.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: 8935204
• MDR Text Key: 155672762
• Report Number: 9612164-2019-03599
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• 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
• Report Date: 10/11/2019

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 Expiration Date: 10/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 53026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 09/25/2019; 10/09/2019
• Supplement Dates FDA Received: 09/25/2019; 10/11/2019
• Date Device Manufactured: 10/01/2018
• 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: 87 YR
• Patient Weight: 91