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); Injury (2348)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal during treatment of the patient¿s short saphenous vein (ssv).Ifu was followed.It is reported that post op scan 2 weeks post procedure showed acute partial thrombus in the popliteal and gastric veins.Patient was prescribed eli quo¿s 2.5mg.5 weeks post this, partial occlusion was still observed.Patient¿s prescription was increased from 2.5mg to 5mg.

Manufacturer Narrative

Additional information: during treatment of the patient¿s short saphenous vein, the tip of the device was place 4cm caudal to the spj.The patient is reported to be doing fine on eliquis bid 5mg, will return for a follow-up appointment.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: 9006392
• MDR Text Key: 160174867
• Report Number: 9612164-2019-03889
• 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
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 52834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2019
• Date Device Manufactured: 09/20/2018
• 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