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); Ulceration (2116)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During procedure, venaseal occluding device was used to treat 7 segments in the great saphenous vein (gsv) in one leg without incident.Patient then received venaseal again and about 4 - 6 weeks after treatment, complained of redness by the access site.Patient was instructed to take medtrol dose pack and contact clinic if symptoms persist.It was discovered that the patient did not take the dose pack nor contacted the office.Patient presented to dermatologist and was placed on antibiotics.The patient has taken the antibiotics prescribed by the dermatologist.Patient is now about 18 months out of treatment date and complaining of slight ulceration and possible e.Coli infection.No further patient injury reported.

Manufacturer Narrative

Additional information: both left and right legs were treated on the same date.The patient first presented with symptoms 4-6 weeks post procedure.The patient is scheduled for a follow-up visit.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient is reported to be doing much better.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the physician reported presence of adhesive at the access site resulting in a 2 cm dark lesion, on one of the 2 legs treated.No issues with the other leg.Patient was not seen in the practice for 18 months, so physician assumed the patient was doing fine.She returned to the facility presenting some minor issues at the access site.Patient was seen by a plastic surgeon to see about removing/exploring the site.This has been performed and patient was left with a small scar.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: 9706326
• MDR Text Key: 179436686
• Report Number: 9612164-2020-00712
• 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,Followup
• Report Date: 03/24/2020

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 Expiration Date: 02/28/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 50547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 02/13/2020; 02/25/2020; 03/13/2020
• Supplement Dates FDA Received: 02/20/2020; 02/28/2020; 03/24/2020
• Date Device Manufactured: 02/21/2018
• 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: 46 YR