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); Reaction (2414)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

No components from either venaseal closure system kit was received for evaluation.No sonographic images were received for evaluation.A single photograph of a glue-like plug in a plastic pouch with zipper closure was received for evaluation.Implant date: month and year only valid.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used a venaseal for the treatment of the great saphenous vein (gsv) as per the ifu in (b)(6) 2018.Local anesthesia was used.Compressions were not performed.The venaseal was advanced to 7cm from sfj.One segment was treated and the vein closed.It was reported that on (b)(6) 2019 inflammation and oozing was reported by the patient at the access site of the procedure.A discharge looking like a small glue plug had exited the access site on its own.The physician prescribed steroids and antibiotics to the patient.Update on jan 24 2019 from the physician stated that the patient is doing better.

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: 8295924
• MDR Text Key: 134695575
• Report Number: 9612164-2019-00387
• 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: 03/19/2019

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 03/19/2019
• 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): Required Intervention