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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Reaction (2414)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

Image review: (physician notes and photo of leg): the physician notes describe two separate patient visits with led to the approval from treatment.The notes indicate symptomatic varicose veins have been identified.The notes did not specifically indicate the varicose veins would be treated using venaseal.Final physician note indicating ablation: "plan: varicose veins of right lower extremity with pain continue aspir-81, notes: right gsv reflux.Schedule ablation.The provided photo shows a leg with necrosis at the suspected access site and proximal from access site which was identified during post procedure follow up according to the customer.Redness around the identified areas of necrosis was identified.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient was treated with venaseal great saphenous vein (gsv) was treated.The vein is reported to have closed.Patient returned for follow-up appointment 5 days post implant and underwent a venous ultrasound which showed a dilated and refluxing left gsv.Patient continues to have left lower extremity aching, burning and cramping with varicosities despite conservative therapy including compression therapy, leg elevation and avoidance of prolonged sitting and standing over a period of 3 months with only partial relief reported.Patient cannot stand during the day without having to sit and elevate legs.It has been reported a reaction occurred post procedure resulting in necrosis at the access site and proximal from access site which was identified during post procedure follow up.Patient had been hospitalised for another condition.This resulted in partial explant of the cyanoacrylate at the access site and at the proximal from the access site.The patient is now reported to have open wounds at the mid and lower leg from the partial explant.Patient has been referred to a wound care centre for treatment.No further patient injuries reported.

Manufacturer Narrative

Additional information: necrosis at the access site was noticed by the physician a few days after the procedure.Access site was an open wound above the ankle.Physician note and image review: the physician notes describe two separate patient visits which led to the approval for treatment.The notes indicate symptomatic varicose veins have been identified.The provided photo shows a leg with necrosis at the suspected access site and proximal from access site which was identified during post procedure follow up according to the customer.Redness around the identified areas of necrosis was identified.Correction: patient age updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 9590515
• MDR Text Key: 175027103
• Report Number: 9612164-2020-00236
• 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: 02/20/2020

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 01/28/2020; 02/14/2020
• Supplement Dates FDA Received: 01/29/2020; 02/20/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 57