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 Problems Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

No components from the venaseal closure system kit was received for evaluation.Three sonographic images of the patient¿s saphenofemoral junction were received.Two of the images show a thrombosis formation extending into the saphenofemoral junction(sfj).The third image shows the thrombosis formation retreated into the great saphenous vein (gsv).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient was treated with venaseal, the procedure went as planned and was performed without incident.The catheter tip was seen clearly 5cm caudal to the sapheno femoral junction (sfj) prior to delivery of adhesive.Compression was used.It was reported the patient returned to the facility for an ultrasound scan 6 days post procedure where a thrombus extension was observed.The patient was prescribed blood thinners equilis (5mgs x 2 daily) for 10 days.Patient returned for second follow-up, it is reported the extension has receded and is now within gsv and not extending out into the common femoral.Patient will finish 10 day rx of eliquis.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8045310
• MDR Text Key: 126350060
• Report Number: 9612164-2018-03084
• 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
• Report Date: 11/07/2018

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 Expiration Date: 06/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 51909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 11/07/2018
• Date Device Manufactured: 06/28/2018
• 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
• Patient Age: 82 YR
• Patient Weight: 61