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 Problem Thrombus (2101)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician used venaseal to treat a patients bulging superficial varicosities in the great saphenous vein (gsv).Extra adhesive was delivered to the area where the blister subsequently occurred.The last treatment was at the black line but no issue near entry site.The vein was successfully closed and the procedure was completed with no issues.There was no redness or deep vein thrombosis (dvt).It was reported that post op the patient developed a blister and it appeared under ultrasound that the varicosity had thrombosed.The area became red at the entry point.The blister was debrided and rx solumedrol pak was prescribed.The patient was subsequently prescribed antibiotics and steroids.There are more blisters forming.The physician does not believe that the patient has a history of sensitivity to adhesive or that this is an infection.

Manufacturer Narrative

Patient is doing better.The wound is reported to have healed.The patient has reported that the leg feels good after the procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received right gsv was treated.The catheter tip was 5cm caudal to the sfj.Extra adhesive was delivered to the osteum of the vv.Clarification of timeline: compression was applied during the procedure and the patient was wrapped for 24hours post procedure.Compression stockings were worn for 2 weeks.Two days post procedure, there was no redness or deep vein thrombosis (dvt).Five days post procedure, there was redness and a possible infection.The patient was prescribed keflex which was taken for 7-10 days.Nine days post procedure, there was no improvement and no evidence that this was an infection.It was reported that post op subsequently, the patient developed a blister.The area became red at the entry point.The blister was debrided and rx solumedrol pack was prescribed.Fourteen days post procedure, debridement was performed.The patient was subsequently prescribed antibiotics and steroids.There are more blisters forming and it appeared under ultrasound that the varicosity had thrombosed.Subsequently, the physician reported having to debride more small glasslike chunks of glue, the patient was prescribed 1 weeks solumedrol dose pack.The patient is to attend a follow-up appointment to debride more glue if needed.It was reported the patient was admitted to hospital for cellulitis then discharged.Has a picc line for prolonged iv antibiotics.She missed her appointment last week because of it.I am seeing her on wednesday.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: five photographic images were received.The images are of the patient¿s right leg at or below the knee from different follow-up office visits.The photographs did not indicate the dates they were taken but have been arranged in a logical progression.The first image shows redness just below the knee and a bandage mid-calf.In the center of the redness there is some blistering of the skin tissue.The second image is of the same area the redness has lightened but an open sore is now present at the knee.The open sore is in the area where blistering was observed in the previous picture.The third image is of the same area and the bandage of the open sore is in the process of being removed.The fourth image is of debridement of the open sore, material debrided is on a square of gauze.The bandage just above the ankle has been removed, an open sore appears to be in the process of healing.The fifth image shows a dark redness where the open sore by the knee was and appears to be healing.The open sore just above the ankle appears to have healed.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: 8325285
• MDR Text Key: 135701438
• Report Number: 9612164-2019-00474
• 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,Followup
• Report Date: 08/13/2019

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 02/19/2019; 06/27/2019; 08/12/2019
• Supplement Dates FDA Received: 03/11/2019; 07/11/2019; 08/13/2019
• 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
• Patient Age: 67 YR
• Patient Weight: 57