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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Patient Problem/Medical Problem (2688)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Implant date: literature article published date (year only valid) endovenous ablation using venaseal sapheon closure system for treatment of great saphenous vein incompetence surgical practice (2017) suppl 1 pg 29 (p35) n/a.If information is provided in the future, a supplemental report will be issued.

Event Description

This abstract aims to analyze the results post use of vena seal in patients with gsv incompetence.This study encompasses clinical examination, duplex ultrasound and patient¿s satisfaction and symptoms.Scores were evaluated at 6 weeks, 6 months and 1 year for 20 patients (27 limbs) treated with vena seal.It is reported technical success was 96%.Two cases developed erythema and hematoma after operation.No major adverse effect or complication, including deep vein thrombosis were detected.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7320917
• MDR Text Key: 101767221
• Report Number: 9612164-2018-00469
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention