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

Model Number VS-402

Device Problem Biocompatibility (2886)

Patient Problem Abscess (1690)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had great saphenous vein (gsv) and short saphenous vein (ssv) treated with venaseal.3 segments treated, the vein is reported to have closed.There were challenges related to location of catheter tip prior to initial delivery of adhesive.The catheter was 5cm caudal to the saphenous femoral junction.Approximately 7 months post procedure during follow-up appointment due to pain and redness on right leg of treated greater saphenous vein, an abscess is also present.Patient was prescribed medrol dose pack.

Manufacturer Narrative

There were no challenges related to location of catheter tip prior to initial delivery of adhesive.After a follow up consultation 8 weeks from the event date, it was noted that the patient has a new area on his tight presenting minimal drainage.Patient is currently taking zantac and ayrtec and will be prescribed a long term, low dose steroid therapy.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was reported that upon last contact, the patient's symptoms were improving.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: redness and pain on the patients right leg is improving.The abscess is resolving.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: a single photographic image of the patient¿s symptoms from one of the follow-up office visits was received for evaluation.The image is of the patient¿s lower right limb below the knee.Near the knee an abscess is present, and redness of the limb is visible below the knee.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the second formed abscess on the patient's right thigh presents minimal drainage.There is minimal improvement in relation to pain and redness.The initial abscess is still present.Patient currently taking the same medication.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: 9289124
• MDR Text Key: 165603046
• Report Number: 9612164-2019-04672
• 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,Followup
• Report Date: 01/24/2020

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: 08/31/2020
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 52441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 11/14/2019; 11/20/2019; 12/13/2019; 12/31/2019; 01/23/2020
• Supplement Dates FDA Received: 11/15/2019; 11/21/2019; 12/17/2019; 01/06/2020; 01/24/2020
• Date Device Manufactured: 08/18/2018
• 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