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

Catalog Number VS-402

Device Problem Migration (4003)

Patient Problem Thrombus (2101)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Image review: a sonogram was received for review.The image confirms material in the common femoral vein (cfv) extending from the junction which appears to occupy approximately 50% of the cfv lumen.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient had great saphenous vein (gsv) treated with venaseal.One segment was treated.One-week post procedure.It is reported there is glue in the junction.The patient is reported to be alive without injury.

Manufacturer Narrative

Additional information: ifu was followed.The catheter was located 5cm distal to the saphenofemoral junction prior to initial delivery of adhesive.Patient was prescribed prednisone.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: 9680331
• MDR Text Key: 178110182
• Report Number: 9612164-2020-00604
• 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: 02/12/2020

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: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 02/12/2020
• 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): Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 74