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 Edema (1820); Itching Sensation (1943)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used venaseal to treat patient¿s great saphenous vein (gsv) and short saphenous vein (ssv) following recurrence of varicose veins after laser surgery.Ifu was followed.The vein is reported to have closed.It is reported one-week post implant the patient presented with an allergic reaction reported as redness and itching.Patient was prescribed anti-histamines and nsaids.Approximately 2 weeks later the patient presented with edema especially around the eye.The patient returned to the hospital 2 days after the edema occurring and has been given a steroid injection.Reaction appears as systemic allergic reaction post venaseal treatment.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the catheter was placed 5cm caudal to the saphenofemoral junction (sfj) prior to delivery of adhesive.Both left and right great saphenous vein (gsv) and short saphenous vein (ssv) were treated.No allergy patch test was performed prior to procedure.Patient's condition is not improving.Patient is returning to hospital often for treatment.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: 9544704
• MDR Text Key: 173714096
• Report Number: 9612164-2020-00061
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 03/27/2020

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 Expiration Date: 04/30/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 55442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 01/05/2020; 03/26/2020
• Supplement Dates FDA Received: 01/07/2020; 03/27/2020
• Date Device Manufactured: 04/17/2019
• 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
• Patient Age: 38 YR