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

Device Problem Biocompatibility (2886)

Patient Problems Rash (2033); Reaction (2414); Thrombosis/Thrombus (4440)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient had the left great saphenous vein (gsv) treated with a venaseal closure device.No issues were reported during the procedure.The patient reported a rash with clear blisters around the incision area around the knee and spread all over their leg, and hives from head to toe 3 days post procedure.The patient reports they are being treated for the allergic reaction by primary care physician and an allergist, believes it is an allergic reaction to the glue from the venaseal procedure.The patient has developed thrombus extension into common femoral vein (cfv) and inflammatory versus infectious etiology.The patient was prescribed a 6-week course of lovenox/pradaxa which was switched to xarelto due to an allergic reaction to the pradaxa.The patient has also bee prescribed augmentin, keflex,prednisone, and benadryl.The patient's status is reported to have improved.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10512981
• MDR Text Key: 206299079
• Report Number: 9612164-2020-03416
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: 09/04/2020
• 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
• Patient Age: 61 YR
• Patient Weight: 70