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

Catalog Number SP-101

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

Patient Problems Erythema (1840); Inflammation (1932); Patient Problem/Medical Problem (2688)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Event date: month and year only valid literature article.Doi: 10.26717/bjstr.2019.17.003040.Venasealtm cyanoacrylate glue rejection following endovenous ablation.Another new complication ps lew, yk tan: department of general surgery, changi general hospital, singapore tt chong and ty tang: department of vascular surgery, singapore general hospital, singapore.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 carry out a procedure in (b)(6) 2017.The right great saphenous vein (gsv) and small saphenous vein(gsv) of a patient with ceap 6 disease were treated.The procedure was described as uneventful.The patient returned approx.2 weeks post procedure with multiple large painless blisters and erythema along the treated gsv & ssv.The patient was treated with anti-inflammatories and antibiotics.All blister eventually burst and exuded white substance over a 6-12 month period.A 12 month scan showed that both the gsv and ssv remained ablated.

Manufacturer Narrative

The anti-inflammatory was arcoxia.The patients' wound is healed and is reported to be doing well.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: 8743408
• MDR Text Key: 149492037
• Report Number: 9612164-2019-02575
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 47678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2019
• Date Device Manufactured: 06/13/2017
• 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: 42 YR