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 Patient Problem/Medical Problem (2688)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used venaseal to treat the a 23cm segment of the great saphenous vein(gsv) on (b)(6) 2018.The procedure was completed without issue.The catheter tip was 5cm caudal to the sapheno femoral junction (sfj) prior to delivery of adhesive and compression was used.It was reported the vein did close.The patient presented on (b)(6) 2018 with a raised red, firm know around the insertion site.The physician treated the patient with 2 rounds of medrol dose packs.Initially, an improvement was noted but then new areas developed on both treated legs.The original areas healed.The physician then administered 40mg prednisone for 2 weeks.The physician reported that the patient didn¿t have any drainage and that a course of antibiotics was used without any change.The physician does not know of any history with the patient that would now have led him to believe that there would be a reaction to the venaseal procedure.The patient had no history of ulcerative colitis.During follow-up with the patient, it was discovered that the patient started taking methotrexate in july for heel cracking.In the physician¿s experience and in research found, this medication¿s main side effect would be boils and skin sores.Patient has stopped the medication and is continuing the dose of prednisone prescribed for another week.The patient is scheduled for further follow up visit.

Manufacturer Narrative

Patient is doing much better.The sores are healing and no new ones have formed.The physician feels that the methotrexate was the issue.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: 8063317
• MDR Text Key: 126905773
• Report Number: 9612164-2018-03157
• 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
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• 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
• Date Manufacturer Received: 11/26/2018
• 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: 70 YR