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

Catalog Number VS-404

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Discomfort (2330)

Event Date 12/05/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 physician used a venaseal closure system to treat a patient¿s great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.A guidewire was used for the insertion of the catheter.Tumescent infiltration was not utilized.Local anesthesia was used.Transducer compression was used.Physician completed the procedure as per the ifu.40cm of vein was treated and vein is reported to have closed.Patient returned on (b)(6) 2023 to have his left leg treated with venaseal.Patient presented with a red itchy rash and mild discomfort over the area on the right leg that was treated with venaseal.The physician decided not to proceed with the venaseal treatment on the left leg as he wants to wait for this to resolve.The physician is treating it as a possible hypersensitivity reaction to venaseal.The physician prescribed the patient a medrol dose pack (day 1 - 30mg, day 2 - 25mg, day 3 - 20mg, day 4 - 15mg, day 5 - 10mg, day 6 - 5mg) and has patient scheduled for a follow up visit on (b)(6) 2023.

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.

Manufacturer Narrative

Additional information: there were challenges related to location of catheter tip prior to initial delivery of adhesive, the physician could not advance the catheter further than distal thigh where they started the initial delivery due to the vein being to small from the distal thigh to sfj.The catheter tip was further than 5cm caudal to the sfj as they started the initial delivery in the distal thigh.The patient had a follow-up appointment ((b)(6) 2023) after completing the medrol dosepack and their symptoms had improved with the itchiness gone and only a little bit of redness still present, but overall the patient has improved.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 ; 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: 18317953
• MDR Text Key: 330376579
• Report Number: 9612164-2023-05914
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: 00763000240776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

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-404
• Device Lot Number: 72198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 01/05/2024
• Date Device Manufactured: 05/11/2023
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 113 KG