MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Local Reaction (2035); Swelling/ Edema (4577)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient reported severe allergic reaction to venaseal glue.The venaseal procedure was carried out on the patient in 2019 and it caused such a horrific reaction that the vein in the patient's leg had to be removed.The patient could not be intubated because of her body's reaction and had to have an epidural.Since then the patient has been in and out of testing and can not go out in the sun without a rash developing or a feeling of her skin on fire.The patient's leg is in contact pain and swells if standing for long periods.It is only the patient's leg that the venaseal glue was used on that has the reaction.The patient thinks that the glue should not be on the market and that it is used too casually by doctors.The patient believes that the glue should only be used for emergencies by an experienced cardiologist and wants to spread her experience so no one else goes through what she has gone through and what she continues to go through.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12187248
• MDR Text Key: 262171434
• Report Number: 9612164-2021-02766
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• 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
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2021
• 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