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); Swelling (2091); Reaction (2414)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was treated with venaseal.Four segments treated over 4 days consecutively.The first procedure covered treatment of the patient¿s right great saphenous vein (gsv).50cm of vein treated and 2.0c of adhesive was used.The second procedure was of the left gsv.50cm of vein treated and 2.0 cc adhesive was used, the third procedure was for treatment of bilateral short saphenous veins (ssv).20cm vein treated and 1.0 cc adhesive was used.The fourth procedure was of the anterior accessory great saphenous vein (aagsv).20cm of vein was treated and 1cc of adhesive was used.No issues reported during treatment.Approximately 2 weeks post implant, it was reported that the patient experienced a full body reaction which included swollen lips, swollen eye lids, swollen hands and rash/hives over the entire body.The patient visited the emergency department and was prescribed prednisone and benadryl.2 days later the patient returned to the emergency department and was prescribed prednisone, ataxra and pepcid.The patient was seen at a follow-up one day later and the reported symptoms are reported to be improving.The patient is now reported to be doing well and is symptom f ree.No further patient injury reported.

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: 9858939
• MDR Text Key: 189585765
• Report Number: 9612164-2020-01250
• 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
• Report Date: 04/27/2020

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: 01/29/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 04/25/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 59