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

Model Number VS-404

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Urticaria (2278); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

B3: exact onset date is not known.See b5 for range of dates.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.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 the great saphenous vein (gsv).Local anesthesia was used.Tumescent infiltration was not used.Transducer compression was used and the vein closed.The ifu was followed.  patient presented for a follow-up on the 24-aug-2023, the patient was seen the week previous due to significant redness and pain along the treated vein.Patient presented on the (b)(6) 2023 with continuous pain and itching and hardness along left gsv.No fevers, chills or body aches.Patient continuing on xarelto and pepcid and started on a medrol dose pack.The patient presented for further follow up on the 29-aug-2023 and it was reported that patient had continuous pain, itching and some hardness along the left gsv.Patient was given medrol dose pack and instructed to continue his pepcid, patient was also started on xarelto.Patient presented to the emergency department on the (b)(6) 2023 because for over an hour/ an hour and a half the patient eyes started to swell to close shut, at the time the patient was also experiencing hives and rashes with itching on the hand and feet.Patient prednisone dose was increased to 60mg for the next 5 days, hydroxyzine 50mg as well as benadryl cream and taking allegra.Patient was also given 2mg of valium as needed to help with sleeping.Patient is still taking xarelto and pepcid.Patients blood pressure is elevated on the increased prednisone dose.

Manufacturer Narrative

Additional information: on the (b)(6) 2023 the left gsv venaseal was performed, no other procedures noted.No challenges or deviations noted.The catheter tip was 5cm caudal to sfj.There was compression of the gsv, there was 5 minutes of compression held.Date of onset of symptoms was (b)(6) 2023.Post procedure doctor started the patient on zyrtec, pepic, and aspirin prophylactically for 2 weeks.Patient started these medications on (b)(6) 2023 along with motrin for pain.The issue is still present.The patients allergic reaction is being treated with an allergist.Per the allergist he felt do to the timing and length of reaction that the patient was allergic to the motrin and aspirin.The allergist instructed him to stop taking these medications.As per the allergist request these two medications have been added to the patients allergy list.At the doctors office visit on (b)(6) 2023 the patient was still having symptoms, but was released back to work with a 3 month follow up unless symptoms worsen.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: 17753854
• MDR Text Key: 323465405
• Report Number: 9612164-2023-04189
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VS-404
• Device Catalogue Number: VS-404
• Device Lot Number: 70612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Date Device Manufactured: 12/16/2022
• 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: Male
• Patient Weight: 121 KG