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); Pain (1994); Swelling (2091)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a venaseal kit to treat a patient¿s right great saphenous vein (gsv) as per ifu.3-days post procedure ultrasound revealed no dvt and everything looked normal.On follow-up visit that was about 1 week after the procedure, a minor edema was noted which was no different to prior to the procedure.9 days later the patient presented complaining they were unable to wear the bandage any longer as it could not be tolerated and was advised to wear compression stocking instead which the patient reported they could not tolerate either.Mild inflammation was present.The patient was told to return for 6-month follow-up ultrasound.The patient returned 6 days later (24 days post procedure) reporting increased pain and swelling but denied any itching or hypersensitivity reaction.This was described as acute onset of major edema which had occurred 2 days prior.Prior to returning for follow-up the patient started taking an old prescription of meloxicam and was advised to continue as well as elevate as much as possible and wear compression stockings.The patient was prescribed nsaids for pain and swelling and advised to wear stockings and to elevate when resting and continue walking.Antihistamine to be taken if suspected hypersensitivity reaction.The patient was also scanned again to check for dvt sent home.The results of this ultrasound study scan showed negative for dvt.The patient returned 6 days later and reported that the edema and pain had begun to subside.All recommendations were reiterated, and the patient was advised to avoid sedentary activity.The patient has been wearing the compression stocking and has no complaints.Patient returned one week later, reporting symptoms had resolved.No further injury reported.

Manufacturer Narrative

Additional information: the patient is doing well 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.

Manufacturer Narrative

Image review: two images of the patient's thighs were received for evaluation.Based on quality of the received images, it cannot be determined pain/swelling that would have confirm post procedure complications.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: 10270600
• MDR Text Key: 198731070
• Report Number: 9612164-2020-02580
• 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: 09/02/2020

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: 06/26/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 08/10/2020; 09/01/2020
• Supplement Dates FDA Received: 08/12/2020; 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR