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 05/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used a venaseal closure system to treat the great saphenous vein (gsv) on (b)(6) 2019 from the ankle to the saphenofemoral junction (sfj).Two (2) days post procedure it was reported that there was partial thrombus from the proximal thigh to the mid calf.There was evidence of flow above the knee indicating that the treatment failed.The patient is not in pain but has been prescribed plavix.

Manufacturer Narrative

Additional information: the catheter tip was placed 5cm caudal to the sfj.No complications reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The patient was treated with 5ml cyanoacrylate (glue).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: six photographs of sonographic images were received.The first photographic image of a sonogram image is a longitudinal image of the great saphenous vein.On the right end of the vein appears to be occluded.The left end of the vein appears to be open ¿ not treated.The second photographic image of a sonogram image is a cross-section view, (transverse ultrasound plane), of the great saphenous vein near the knee.The vessel appears to be open with a circular mass approximately at ¿7 o¿clock¿ in the vessel, (upper left corner of the cine).The third photographic image of a sonogram image is a longitudinal image of the great saphenous vein.Based on the computer-generated coloration of vein due to blood flow within the vein; the vein appears to be open ¿ not treated.The fourth photographic image of a sonogram image is a longitudinal image of the great saphenous vein near the knee.The vessel appears to be open ¿ not treated.The fifth photographic image of a sonogram image is a longitudinal image of the great saphenous vein mid-thigh.The vessel appears to be open ¿ not treated.The sixth photographic image of a sonogram image is a longitudinal image of the great saphenous vein.The vessel appears to be open ¿ not treated.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.

• 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: 8631122
• MDR Text Key: 145737048
• Report Number: 9612164-2019-01885
• 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,Followup,Followup,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 52795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2019
• Date Device Manufactured: 09/13/2018
• 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: 81 YR
• Patient Weight: 67