MAUDE Adverse Event Report: COVIDIEN 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 Irritation (1941); Itching Sensation (1943)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2016, the physician treated a patient at the great saphenous vein and anterior accessory great saphenous vein using a venaseal device.Ifu was followed.3 veins were treated and all 3 closed.Physician accessed 3 sites - 2 on right and 1 on left.Treated approx.55 cm right gsv.Treated approx.25 cm left gsv.Treated approx.10 cm right accessory vein connected to gsv.It is reported that the day after the procedure the patient began to experience increased redness at treatment site, hot to touch, itchiness and chills.Physician provided nsaids to patient.Additional treatment was then provided - oral steroid, specifically solumedrol (2 courses) and the continued use of benadryl and hydrocortisone cream (at affected areas).On (b)(6) 2016, the patient was still tender and warm to touch but with less redness.Five days later, patient had red itchy hives all over body and a swollen face and eyes.Primary care physician increased oral steroid dosage to 60 mg.On (b)(6) 2016, physician stated the patient had exposure to dermabond without reaction.Patient was responding to oral steroid regimen.Once initial steroid pack was completed, patient's primary physician prescribed a 40 mg treatment of oral steroids.Although symptoms were marginally improved, patient was still experiencing itchiness/redness/areas hot to touch on legs and side.At 3 week follow-up, hives on patient's arms/legs/side/face were reported to be gone.However, pain in the legs was worse.Physician said the patient was doing well on oral steroids and treatment was being tapered off slowly.All blood work came back normal.Additional blood work performed to test for possible drug induced lupus.Results came back negative.

Manufacturer Narrative

Additional information received 11/oct/2016: patient reported to have edema on both legs.Still gets red when standing, itchy and hot.Patient broke out in hives again.Oral steroid (prednisone) dosage was lowered to 40mg from 60mg.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient status update as of (b)(6) 2016: patient had not improved.A rash and/or some inflammatory response had migrated to patient's face.Physician suspected the patient has "chemically induced lupus" however no further testing or work up has been performed.A good faith effort will be made to obtain the applicable information relevant to the report.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): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6016389
• MDR Text Key: 56930312
• Report Number: 2183870-2016-00623
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2017

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
• Device Lot Number: 42356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/06/2017
• Supplement Dates FDA Received: 11/09/2016; 04/26/2017; 09/26/2017
• 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