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 Reaction (2414)

Event Date 07/24/2018

Event Type  Injury  

Manufacturer Narrative

Estimated date based on received information image analysis: a single photographic image of the patient¿s symptoms was received for evaluation.In the photograph a slight redness is noted on the patient¿s thigh over the treated vessel.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used a venaseal kit as per the ifu to treat the patients right great saphenous vein (gsv).Local anaesthesia was used.It is reported that when the 0.035 guidewire from the venaseal kit was introduced it would not track due to vessel tortuosity.A non-medtronic guidewire was able to be passed and positioned at the saphenofemoral junction using ultrasound guidance.Physician then attempted to pass the 80 cm/7 f introducer sheath/dilator over the non-medtronic guidewire, but it wouldn't pass due to vessel tortuosity.The system was pulled out and access was achieved in a similar fashion approximately 5 cm above the original attempt.The microcatheter was placed and the 0.035 guidewire was positioned at the sfj.The microcatheter was removed and the 80cm/7f sheath was passed over the wire and positioned 5cm from the saphenofemoral junction.Compression of the gsv was carried out for 3 minutes at the most proximal site and then 30 seconds after each new aliquot.Twelve segments were treated and the vein successfully closed.It was reported that redness gradually appeared over the treated area starting the first week post procedure.During the one month follow-the patient was offered a prescription for prednisone but declined and wished to be treated with over the counter medication.The patient contacted the clinic five days later and agreed to a tapering medrol dose pack over a six day course.The patient had over a 50% resolution of her symptoms within 12 hours.The patient still has some discoloration from light pink to red and still has limited duration of walking tolerance.The area is very tender to touch from access site to mid-thigh with the medial knee being the most sensitive.However, she feels that it is 75% improved.The physician feels possibly patient has a sensitivity to the adhesive but can¿t be sure.Physician reports symptoms were not characteristic of superficial thrombophlebitis (stp) as it would have shown up on the ultrasound and confirmed that an infection was not present.

• 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: 7888616
• MDR Text Key: 120692950
• Report Number: 9612164-2018-02433
• 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
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 51148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Date Device Manufactured: 04/23/2018
• 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
• Patient Age: 68 YR
• Patient Weight: 37