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

Catalog Number VS-402

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

Image review: three sonographic images were received for evaluation.The three images include the sfj, common femoral vein, and femoral artery.Image 1 is of the left common femoral vein and the sfj in a longitudinal plane.Image 2 is of the left common femoral vein and the sfj in a transverse plane.Image 3 is of the left common femoral vein and the sfj in a longitudinal plane.A mass of thrombosis can be seen in all three images.Based on the quality and clarity of the images it is not possible to positively determine if the thrombosis mass includes adhesive.No components from the venaseal closure system kit were received for evaluation.No photographic images of the patient¿s symptoms were received for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a patient was treated with vena seal as per the ifu in the great saphenous vein(gsv).Approximately a 30cm length was treated with 1 cm of cyanoacrylate.The catheter tip location was 5cm caudal to the saphenofemoral junction (sfj) prior to initial delivery of the adhesive as per the ifu.The patient returned for a follow up study and it was found that glue had extended close to the common femoral vein.The patient was prescribed blood thinners as a result of the glue extension.

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.

• 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: 7762187
• MDR Text Key: 116405933
• Report Number: 9612164-2018-01983
• 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
• Report Date: 10/03/2018

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: 07/12/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 09/04/2018; 10/03/2018
• 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