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 Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a venaseal to treat the gsv (great saphenous vein).Ifu was followed and the device was prepped without issue.The procedure was completed using a venaseal.No issues occurred during the procedure.It was reported post procedure the patient had inflammation around the area of the treated limb, pain and inflammation that made it painful to walk.This was initially treated with motrin and heat compress but the inflammation returned and there were three areas of the skin where it seemed to erode through the skin creating three ulcer looking lesions.No steroids were given and no allergy test or antibiotics were given.At 4 months post procedure the customer decided to extract the gsv that had venaseal implanted in it.

Manufacturer Narrative

Additional information: three screen shots from a smart phone were provided for evaluation.In one of the screen shots a photograph of the patient¿s left inner thigh was provided for evaluation.The photograph is of a wound with an orangish center.It is not possible to positively confirm from the photograph if this is an eruption of venaseal adhesive.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Physician reported that patient's thigh issues healed but the venous ulcer has returned.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: 7836897
• MDR Text Key: 118889020
• Report Number: 9612164-2018-02233
• 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,Followup
• Report Date: 01/15/2019

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: 08/29/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 09/27/2018; 12/18/2018
• Supplement Dates FDA Received: 10/01/2018; 01/15/2019
• 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