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 Abscess (1690); Reaction (2414)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

One image was received from the customer.This picture shows redness and swelling of the patient leg.No component of the venaseal closure system kit was returned for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient received a venaseal treatment for closure of lower portion of great saphenous vein (gsv).The patient presented with hypersensitivity approximately 1-week post procedure.The patient was treated with a medrol dose pack, after which it was reported that the patient hypersensitivity had improved.Approximately 1 month later the hypersensitivity was persisting and continued after a full round of steroid medication.Lesions resembling abscesses in the treatment zone were reported.

Manufacturer Narrative

Updated information: patient continued to experience symptoms.The surgeon decided to explant the venaseal treated vein.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The patient had surgery to remove the vein and all venaseal product.This went as planned however, the procedure date is unknown.Patient is clinically doing better.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information this event was also reported in medwatch reports mw5081095 <(>&<)> mw5081096.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: 7946091
• MDR Text Key: 123057323
• Report Number: 9612164-2018-02666
• 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,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• 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
• Date Manufacturer Received: 12/12/2018
• 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