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

Device Problem Biocompatibility (2886)

Patient Problems Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Swelling/ Edema (4577)

Event Date 03/08/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A patient reported had a venaseal procedure and since then been in/out of primary doctors office/emergency room with allergies experiencing severe allergic reaction.Right leg swollen, itching, loosing hair.The glue was placed inside the right leg.The glue might be taken out by surgery.The patient noticed something was wrong soon as they walked away from the physician office, but thought it was mild and maybe could go away with tylenol and ibuprofen as directed by the treating physician.Patient is seeing an allergist to confirm.The area is warm to the touch and irritated.The patient was fine before and now is been stuck with depression due to this none stop itch.In (b)(6) 2022 only worked two days due to severe pain and right leg swollenness.Doctor who inserted the venaseal prescribed steroids and also the emergency room.Doctor who inserted venaseal said there is nothing she can do, so she tells me to go see my primary physician.Patient was prescribed 20mg famotidine 10 days post procedure.Patient was also prescribed 50mg prednisone on 10 days post procedure, 13 days post procedure and approximately one month post procedure respectively.Patient was prescribed 10mg cetirizine 21 days post procedure.Patient went to allergy physician who confirmed that patient is allergic to venaseal.Patients primary doctor has referred patient to general surgeon to determine what to do with this case.No further 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 MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14589560
• MDR Text Key: 293249731
• Report Number: 9612164-2022-02122
• Device Sequence Number: 1
• Product Code: PJQ
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• 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: Female