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 Problems Cellulitis (1768); Skin Inflammation (2443)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occluding device to treat a segment in the great saphenous vein (gsv).Physician also performed sclerotherapy on some distal segments after venaseal procedure.Two days post procedure, follow up ultrasound was performed which showed that most of gsv closed with one small segment mid gsv still patent.But no dvt or complications.Four days post procedure, patient presented to hospital with cellulitis and fever.Patient was treated with intravenous antibiotics in the hospital and was discharged after two days.Patient was prescribed on oral antibiotic therapy followed by wound care.Bacterial culture test was carried out but there are no details of the pathogen responsible for the infection.

Manufacturer Narrative

Image review: a single photograph of the patient¿s right inner thigh was provided for evaluation.The patient¿s thigh exhibits swelling and redness in the area of the great saphenous vein.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient condition has resolved.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: 9231441
• MDR Text Key: 164281782
• Report Number: 9612164-2019-04481
• 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: 12/12/2019

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: 10/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 53051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 10/23/2019; 10/24/2019; 12/11/2019
• Supplement Dates FDA Received: 10/24/2019; 10/30/2019; 12/12/2019
• Date Device Manufactured: 10/02/2018
• 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): Hospitalization; Required Intervention