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

Catalog Number VS-402

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occluding device during procedure to treat bilateral great saphenous vein (gsv).The ifu was followed.It was reported that procedure was completed.Patient developed reaction a week later.Patient had venaseal on bilateral gsv's.Patient had a reaction to the glue of redness, itching, swelling and blistering.Patient was checked for dvt , but ultrasound was negative.Patient was put on antibiotics and told to take over the counter benadryl.Patient stated that after taking benadryl the itching subsided.Took almost 3 weeks for side effects to completely go away.There was no further patient injury reported.

Manufacturer Narrative

Image review: five photographic images of the patient¿s symptoms were received in medtronic investigation lab for evaluation.Redness, inflammation and blisters were observed on the patient skin.The redness extends to the treated site.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: 23cm of the right great saphenous vein and 35cm of the left great saphenous vein were treated in separate procedures, with approximately one week between treatments.The total volume of adhesive administered is unknown.There were no challenges or deviation in relation to location of catheter tip prior to initial delivery of adhesive and the catheter was 5cm caudal to the saphenous femoral junction.Compression of gsv was performed.The reaction was observed along the treated area, knee to ankle ble.The issue has resolved and the patient is doing fine.Both legs had the reaction noted.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: 10143352
• MDR Text Key: 194801122
• Report Number: 9612164-2020-02184
• 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: 07/14/2020

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 Expiration Date: 06/30/2021
• Device Catalogue Number: VS-402
• Device Lot Number: 55955
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 06/09/2020; 07/10/2020
• Supplement Dates FDA Received: 06/16/2020; 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 90