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

Catalog Number VS-403

Device Problem Biocompatibility (2886)

Patient Problem Urticaria (2278)

Event Date 01/19/2024

Event Type  Injury  

Event Description

A physician used a venaseal closure system to treat a patient¿s great saphenous vein (gsv).The lumen was not flushed prior to use.The ifu was followed during preparation, procedure, post-procedure.A guidewire was used during catheter insertion and placement.Tumescent infiltration was not utilized.20 segments were treated and the vein was reported to have closed.1 day post treatment systemic urticaria started and the patient was prescribed 30mg steroids 4 days later.Next day t patient consulted a medical clinic for chronic pulmonary hypertension and at that time, was also diagnosed with systemic urticaria and prescribed 125 mg of solumedrol.The patient was admitted to hospital due to systemic urticaria.The patient was being monitored with steroid administration.A drug-induced lymphocyte stimulation test (dlst) was scheduled.Patient still had hives in the morning but things seemed to be getting better in the afternoon.Medications included optorabi, adsilica, and opsumit.Patient has pulmonary hypertension and a history of infection in left lung cyst, so the intention was to avoid using steroids for too long.Patients eyes were swollen due to eyelash extensions.When steroids dosage was gradually reduced (from 50mg to 40mg), there were symptoms of redness and itching on the cac treatment site.Approximately 3 weeks post initial procedure bilateral gsv was removed by making incisions of about 3 cm in 4 places on the left and 3 places on the right and pull out partially and extracted.Dlst test was negative.Since the test is performed while using steroids, there is a possibility of a false negative result.One week post gsv removal the patient was discharged from hospital.Steroids have been reduced to 20 mg.After the steroid completion, the dlst re-examination and patch test are also under consideration.

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.

Manufacturer Narrative

Additional information: there were no challenges or deviations related to location of catheter tip prior to initial delivery of adhesive and was the catheter tip was 5cm caudal to sfj.Image analysis:4 images were returned for review.Film image 1: ¿image received of an apparent rash present on the back of a patient, consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿.Film image 2: ¿image received of an apparent rash present on the back of a patient, consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿.Film image 3:¿image received of an apparent rash present on the inner legs of a patient, consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿.Film image 4: ¿image received of an apparent rash present on the back of a patient, consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18774836
• MDR Text Key: 336187587
• Report Number: 9612164-2024-00925
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female