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); Rupture (2208)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal to treat the patient¿s entire great saphenous vein (gsv).Procedure was completed as per ifu.Over 1-year post procedure the patient has developed an ulcer above the access site.Ultrasound carried out shows the implant appears to be ok.The patient appears to have a ruptured varicose vein which is suspected to be the cause of the ulcer.Infection is present.The ruptured varicose vein appears unrelated to the venaseal procedure when scanned under ultrasound.Infection appears to be unrelated to the venaseal implant.Antibiotics treatment was prescribed.The has been referred to infectious disease and once the infection is clear, the varicose vein will be treated.

Manufacturer Narrative

Image review: a single image of the patient¿s leg showing the ruptured varicose vein and wound was received.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: 9334519
• MDR Text Key: 166756135
• Report Number: 9612164-2019-04779
• 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: 12/23/2019

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: 06/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 51643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 12/23/2019
• Date Device Manufactured: 06/01/2018
• 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: 65 YR