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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Rash (2033); Reaction (2414)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient received venaseal treatment of the great saphenous vein (gsv).The section treated is reported from the junction to the most distal access point below the knee.Procedure was completed without issue.It is reported the patient had a systemic allergic reaction resulting in hospital admission.Patient presented with systemic rash/hives.The patient is reported to have informed the physician post procedure of a significant reaction they experienced to medical adhesive previously.The patient has received an allergy consult and it has been recommended the patient has the vein removed.The patient remains hospitalized and is on oral steroids, benadryl, and zyrtec.

Manufacturer Narrative

Additional information: the patient is currently in facility.The patient is expected to have the procedure to remove the vein two weeks after the implanted date.The patient was consulted on the case, but was not given any other additional treatment.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the vein was removed as scheduled.The patient met with the physician a few weeks ago and is reported to be recovering well.The physician mentioned that if the procedure was to done again, that it would be recommended to do an endoscopic dissection of the vein, but leave it in place.Then incisions top and bottom to take the vein out.There were a couple of side branches that had glue in them and were hard to find after the gsb had been taken out endoscopically.The physician mentioned if it was still in place, the procedure would have been much easier.The physician comments that the patient is doing well in the outpatient follow up visit and confirmed that the patient's condition has fully resolved.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: 9773943
• MDR Text Key: 181546753
• Report Number: 9612164-2020-00954
• 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
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: VS-402
• Device Lot Number: 54221
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/02/2020; 03/31/2020; 05/15/2020
• Supplement Dates FDA Received: 03/04/2020; 04/03/2020; 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR