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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Thrombus (2101); Foreign Body In Patient (2687)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had 31cm of great saphenous vein (gsv) treated with venaseal.Procedure completed as per ifu.The catheter tip was placed 5cm caudal to the sfj.Diameter at the sfj was reported to be very large so extra glue was delivered.1 aliquot was delivered, and the catheter was pulled back 1 cm.The second aliquot was delivered, and catheter pulled back 3cm.Next 2-3 aliquots delivered and the catheter was pulled back 3cm.The vein was being compressed by ultrasound probe.2.5 cm proximal to the catheter tip was observed closely during adhesive delivery and did not observe the vein open up.After 3min compression, the cfv and sfj were checked and was fully compressible.Hyperechoic with posterior shadowing was visualized at 5cm and distally.The remainder of saphenous vein was treated.31cm of vein treated.It is reported the patient developed echogenic material in the sfj and cfv immediately after venaseal procedure.Patient prescribed eliquis.Patient awaiting post op ultrasound scan.No further issues reported.

Manufacturer Narrative

Additional information: 21 cm of the great saphenous vein was treated and a total of 10 volume of venaseal adhesive were used.Patient prescribed eliquis 10mg twice a day for 7 days and 5mg twice a day for 3 weeks and ibuprofen 600mg three times a day for 5 days.Patient recovered post procedure.There is no presence of edema or tenderness to the right leg.A follow up ultrasound carried out 5 days post procedure still showed the presence of the echogenic material.No further patient injury was reported for this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient continues to do well.Ultrasound was performed approximately 1 month after the procedure and the findings remain the same.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient had a follow up appointment.The sonographer reported that the patient continues to do well and will continue taking the xarelto for one more month.The ultrasound image is reported to be the same, with no changes seen.The nurse practitioner reported that the physician is not worried about the issue anymore and the echogenic material seen in the cfv has not moved and is not obstructing flow.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: fifteen sonographic images were received for evaluation.Seven of the images are of the patient's venous lower extremity saphenofemoral junction (sfj) and common femoral vein (cfv).Sonographic reflective masses were observed, indicating possibly thrombus material.The next four screen annotation indicates the right cfv and sonographic reflective masses were observed in the images indicating possible thrombus material.The last four of the images indicate they were taken 3 days after the initial images, with the screen annotation of the right cfv.The amount of sonographic reflective mass observed, indicate possible thrombus material which appears to have been reduced.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: detailed information received for the duplex image findings during patient follow visit approximately 2 months after the procedure.Patient was on eliquis 5mg bid.Chronic right leg dvt that extents in the cfv about 14 mm past the sfj was noted.Right cfv appears about 80% compressible.Clear and compressible sfv, popliteal, gastrocnemius and posterior tibialis without evidence of thrombosis on the right leg.Right gsv appears ablated from the knee.There is no evidence of acute deep vein thrombosis or deep vein influx chronic r cfv dvt, 80% recanalized.No femoral-popliteal dvt.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 9472979
• MDR Text Key: 176320164
• Report Number: 9612164-2019-05183
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/05/2020

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
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/16/2019; 02/03/2020; 02/20/2020; 04/13/2020; 04/29/2020
• Supplement Dates FDA Received: 12/23/2019; 02/06/2020; 02/24/2020; 04/14/2020; 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 62