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

Model Number VS-403

Device Problem Biocompatibility (2886)

Patient Problems Dyspnea (1816); Local Reaction (2035); Urticaria (2278)

Event Date 07/05/2023

Event Type  Injury  

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.

Event Description

A venaseal closure system was used for treatment of 1 segment of the right great saphenous vein (gsv).The lumen was flushed prior to use.Local anesthesia was used.The ifu was followed.Procedure was completed and post op us showed no dvt and subsequent ctpa showed no pe.There were no challenges or deviations related to the location of catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to sfj and compression of gsv was applied.The vein closed.It was reported the patient developed skin irritation (hives) at puncture site near right knee 7 days after venaseal procedure in the right leg.Hives developed up the thigh towards groin and shortness of breath / feeling unwell developed with presentation to emergency department on with steroid treatment (po clindamycin 450mg) with gradual stepdown to loratidine 10mg before ceasing which reduced the hives.It is suspected to be an allergic reaction to the cyanoacrylate in venaseal.Patient was discharged from hospital 9 days later and was due to see doctor again.It is reported the patient¿s symptoms are improving as they continue steroid treatment.The patient will be referred to an allergist in the coming months to test for cyanoacrylate hypersensitivity.

Manufacturer Narrative

Image analysis one image was returned for review.¿image received of 3 pictures showing a rash developed on a patients right leg, consistent with the reported event.Lot/batch number of the venaseal device or venaseal glue vial could not be confirmed based on the returned image.¿ 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: VENASEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17507876
• MDR Text Key: 320856464
• Report Number: 9612164-2023-03646
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VS-403
• Device Catalogue Number: VS-403
• Device Lot Number: 70941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Date Device Manufactured: 01/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female