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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problem Thrombus (2101)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occlusion device during procedure to treat a segment in the great saphenous vein (gsv).It was reported that venaseal procedure and closure of gsv was successful and patient states that ankle swelling is already improved.Patient was being prepped for treatment of her contralateral leg when patient asked physician about normal post-op tenderness physician took a quick look with ultrasound and made the incidental finding of thrombus extension from treated gsv into the cfv, >50% occlusive, patent by color doppler.Thrombus was initially identified at patient's 72 hour follow up ultrasound exam post op extending from adhesive up to the confluence of sfj and cfv, however now the thrombus "tail" extended into the cfv (thrombus extension/ progression from several days ago).It is non-obstructive by doppler color flow and is >50% occlusive.Physician then cancelled treatment of the contralateral leg and began anticoagulation treatment.The patient is completely asymptomatic and this was an incidental finding.No further patient injury reported.

Manufacturer Narrative

Additional information: the physician confirmed that the patient is doing well and has received no other treatment besides anticoagulant therapy.The physician suspects that long-term anti-coagulation may be required and has referred the patient to her hematologist/oncologist for future care.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 10257604
• MDR Text Key: 198712201
• Report Number: 9612164-2020-02531
• 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
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention