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

Catalog Number VS-402

Device Problem Migration (4003)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

Image review: a 15-second video of sonographic images was received for evaluation.In the video a sonic reflective mass within an area of vessel expansion is seen to vibrate.Without the aid of anatomical landmarks, it is not possible to identify the location of the sonographic video.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient was treated with venaseal.One segment of great saphenous vein (gsv) treated.Procedure completed as per ifu.It is reported that there is possible adhesive in the sapheno femoral junction (sfj).The patient is reported to be doing fine and will be returning for a follow-up appointment in one month for a consult and ultrasound.Thirteen days post procedure, patient returned for an ultrasound scan.There still appears to be adhesive extending into the cfv.The patient¿s health is good and reports no symptoms, physician will continue to follow the patient over the long-term and will notify of any issues.

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: 9206431
• MDR Text Key: 162810591
• Report Number: 9612164-2019-04412
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• 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
• Date Manufacturer Received: 11/12/2019
• 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): Hospitalization