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

Model Number VS-402

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During procedure, physician used venaseal occluding device to treat a segment in the great saphenous vein (gsv).Four days post procedure, it was reported that patient experienced a hypersensitivity reaction.The skin irritation was present along the gsv-junction to the knee.The patient's second venaseal procedure was cancelled due to the hypersensitivity and the second procedure was completed with rf ablation instead.Physician prescribed a medrol pack.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional information; 38 cm of the left great saphenous vein were treated with venaseal.The volume of adhesive administered is unknown.The second venaseal procedure was intended to treat the opposite leg, but rf ablation with a closurefast catheter was performed instead without issue.Patient condition showed signs improvements since taking the prescribed medrol, but the current patient health status is unknown.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: 9429775
• MDR Text Key: 170056304
• Report Number: 9612164-2019-05033
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00643169986268
• UDI-Public: 00643169986268
• 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: 03/04/2020

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: 02/28/2021
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 54831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/06/2019; 12/11/2019; 03/03/2020
• Supplement Dates FDA Received: 12/10/2019; 01/08/2020; 03/04/2020
• Date Device Manufactured: 02/28/2019
• 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