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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Vasoconstriction (2126); Thrombosis/Thrombus (4440); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 05/01/2023

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 patient had venaseal procedures done on both legs at different times.In (b)(6) 2023, a patient underwent a venaseal procedure on his right leg to ¿close off the gsv only¿.It is the reporters understanding that the physician had ¿trouble inserting the tube into his leg¿ but was not sure of the details and whether it was a device issue or not.After the procedure, the patient had an ultrasound that showed everything was looking okay.However, three days later the patient experienced a lot of pain and irritation and his leg was very swollen.Approximately 1 weeks post the procedure the patient presented to the emergency room and was diagnosed with a blood clot in their right leg, between the knee and the thigh.In the er, the patient was prescribed with a blood thinner.However the cardiologist told the patient not to take the blood thinner, so the patient did not start the blood thinner.The patient continued to have issues with his right leg including leg spasms.The patient presented to the emergency room in (b)(6) 2023 and was found to have a blood clot again in the right leg.The patient followed up with their family doctor and was prescribed xarelto and has been taking it ever since.Patient had a follow up ultrasound on right left done on ((b)(6) 2023) and according to the patient representative the ¿blood clot is still there¿.Patient is now seeing a new cardiologist <(>&<)> a hematologist for the care of his blood clot <(>&<)> to follow up regarding his left leg immobility <(>&<)> continued leg spasms.

Manufacturer Narrative

Additional infomration: patient is still experiencing continuous problems since their venaseal procedures.They were in a great deal of pain which was expressed to the physician who preformed the procedure.Patient was prescribed prednisone to try to reduce the swelling issues and is no longer seeing the physician who preformed the venaseal procedures.It is reported that in one of the procedures the target vessel had the catheter advanced but product was not deployed as the gsv was small and spasming.Right lower extremity was cleaned with betadine solution and draped with aseptic technique.Site of the venous access was anesthetized with xylocaine 2%, the vein was accessed using ultrasound guidance and the seldinger technique, a guide wire was introduced through the needle, which was then exchanged over the guide wire for a 7f sheath.The venaseal catheter was placed into the vein through the sheath.Proximal gsv was small or spasm so actually catheter was placed very distally from the junction.Under the ultrasound guidance the proximal closure was done with 2 deployments of the glue within 1 cm with 3-minute compression and then catheter was withdrawn with usual technique with deployment of the glue every 3 cm with 30 seconds compression through the whole course of the vein.Post procedurally compression dressing was placed.Following the procedure patient had bleeding from the site which was addressed, but their legs are now immobile and painful.Patient indicates that during a venaseal procedure they experienced multiple needle sticks during treatment of their right leg.During 2 separate appointment's to treat the left and right leg they were not given enough recovery time at the office.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: 17995946
• MDR Text Key: 326384336
• Report Number: 9612164-2023-04835
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 12/01/2023
• 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