MAUDE Adverse Event Report: COVIDIEN LLC VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ulceration (2116); Patient Problem/Medical Problem (2688)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

Submission attempted dec 21 2016, however transmission failed.Message received states "failure input date can not be greater than today." resubmitting jan 04 2017.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

It was reported that the physician performed a bilateral great saphenous vein(gsv) procedure on a patient in (b)(6) 2016 using a vena seal closure system without incident.No tumescent infiltration or compression was used.Several segments were treated and the vein was reported to have closed.It was reported that patient experienced phlebitis one day after the procedure.The contralateral limb, which was also treated, is normal.Within 1 month of treatment a patch of discoloration appeared 20 cm proximal to the access site on one leg.This developed into an ulcer like wound which healed several weeks later with antibiotics however reappeared several months after.Patient was admitted to hospital on (b)(6) 2016.Patient was placed on iv antibiotics and sent to surgery to have the vein excised.Physician had to explore deeper into the tissue and bone, thus this was more invasive than was first thought.Patient w as discharged and put on iv antibiotics for 10 days.Patient saw a surgeon on (b)(6) 2016 who expressed concerns that the remaining segment was causing an issue and should be excised.Patient was diagnosed with deep vein thrombosis on (b)(6) 2016.Medtronic became aware that the patient exposed the wound to salt/sea water one day post the initial procedure.The patient was discharged after four antibiotic changes on (b)(6) 2016.On dec 12th 2016, medtronic became aware that the patient has been placed on 24 hour antibiotic pump and it was reported that this is helping to resolve the infection.However, the patient was brought back to have remaining vein segment removed on (b)(6) 2016.The remaining segment, with the cyanoacrylate implant, was successfully removed from the right leg.The patient¿s left leg remains unaffected.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): COVIDIEN LLC; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN LLC; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6221828
• MDR Text Key: 63842608
• Report Number: 3011410703-2016-00023
• 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
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention