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 Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 09/03/2018

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 venaseal for treatment of 70cm of the patient¿s great saphenous vein (gsv) as per the ifu on (b)(6) 2018.There were no issues with the procedure; the catheter tip was easily viewed by ultrasound and was 5cm from the sfj junction.During a follow-up visit the vein was viewed by ultrasound and was seen to be closed and normal.The patient had no complaints.Nine days post procedure patient called the office with pain and inflammation at different sites on his treated leg.The patient went to the emergency room (er) where his white blood cell (wbc) count was noted to be 30,000 along with positive blood cultures.The patient was taken to the operating room (or) where 2-4 incisions were made to wash and clean out abscess pockets.The patient was prescribed antibiotics.The treated vein was not explanted.Medtronic connected with the vascular surgeons in the practice.They believe that the patient has suppurative thrombophlebitis at an aneurysmal segment and a large branch point.There was no allergic reaction at any other location or infection.

Manufacturer Narrative

Additional information received: patient is making a full recovery.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: 7929382
• MDR Text Key: 122455696
• Report Number: 9612164-2018-02619
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 20643169986262
• UDI-Public: 20643169986262
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 51660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2018
• Date Device Manufactured: 06/11/2018
• 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: 65 YR