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 Abscess (1690); Unspecified Infection (1930); Irritation (1941)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal during procedure to treat the great saphenous vein (gsv).Post procedure, patient presented with entire lower leg infection with abscesses.It was reported that the leg infection required open surgery and explantation of venaseal from gsv.No further patient injury was reported for this event.

Manufacturer Narrative

Additional information: vein stripping was carried out to remove the venaseal implant under general anesthesia.The physician who performed this surgery did not carry out the initial venaseal implant procedure.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: 9451319
• MDR Text Key: 173272091
• Report Number: 9612164-2019-05110
• 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
• Report Date: 03/23/2020

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 12/12/2019; 03/20/2020
• Supplement Dates FDA Received: 12/17/2019; 03/23/2020
• 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