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

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994)

Event Date 11/11/2022

Event Type  Injury  

Event Description

A patient was treated with venaseal in the left great saphenous vein (gsv) in (b)(6) 2022.The ifu was followed.Local anesthesia was used and hand compression was used.No challenges or deviations related to location of catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to sfj.Patient reported a reaction a few weeks post procedure and prednisone was prescribed to address the reaction.Which then went away after 1 treatment of prednisone. the patient returned in november for venaseal treatment right gsv.Patient immediately experienced reaction to cyanoacrylate (ca) including itching, pain, circumferential redness along the vein.The patient was given 2 dosages of prednisone to address this a few weeks post procedure, it initially improved for a while however, by january, nodules began to form along the treated area on both legs.Patient was admitted to hospital on (b)(6) 2023 the reaction had not improved after the 4 treatments of medrol/ prednisone since the treatments in (b)(6) 2022 and (b)(6) 2022.The on call vascular surgeon decided to keep patient for observation over the weekend and no medical action was taken.The patient has an open wound, pain along the treated vein, bumps in different spots one on the right leg and two bumps on the left leg.The issue is still ongoing.At this time, the nodules around the legs are not creating any pains or infection.There has been some improvement around the wounds around the nodules noticed, therefore, the physician is monitoring the patient further to see if patient will gradually improve.

Manufacturer Narrative

Image analysis: images were provided and are consistent with a ¿reaction to cyanoacrylate (ca) including itching, pain, circumferential redness alon g the vein¿, ¿open wounds¿ and ¿bumps along the treated veins¿.Images 1 and 2: images 1 and 2 are photos of the patient¿s leg ¿ medial/posterior calf and knee.There is no time stamp on these photos, so it is unknown at what stage of the reported event they align with.It is unknown if this is the left or right leg.The surface of the skin, in a line, is red and dry.Image 3: this image shows the patients leg from the thigh to the ankle.On the medial calf, we see 2 large circular areas of red and inflamed skin.The more distal of these areas contains what appears to be two wounds, with eschars.These appear raised, with a small darkened hole in the proximal of the two.There is no time stamp on these photos, so it is unknown at what stage of the reported event they align with.Image 4: there is no time stamp on this photo, so it is unknown at what stage of the reported event they align with.It is not identifiable what area of the skin this image is of.There is red and dry skin, surrounding a raised granuloma like wound with overlying eschar tissue.Image 5: there is no time stamp on this photo, so it is unknown at what stage of the reported event is aligns with.It is not identifiable what area of the skin this image is of.This area appears to have been covered with a dressing that has been removed to reveal two raised wounds.There is red and dry skin on one of the raised lumps with a white area in the center.The other raised area, directly next to it, appears to be covered with an eschar.Image 6 and 7: these show a wide and close up view of the patient¿s medial calf.In image 6, the medial calf has a line of red and dry skin extending from the knee down distally towards the ankle.The lower half of the calf has two-three circular wounds, varying in size.Image 7 is a close up view of the lower part of the patients medial calf with two larger raised areas of inflammation /wounds visible.A dark eschar is visible between these two inflammation points.There is no time stamp on these photos so it is unknown at what stage of the reported event they align with.There is no time stamp on these photos so it is unknown at what stage of the reported event they align with.It is not identifiable what area of the skin all of the image provided for evaluation are of.There is no indication from the images provided for evaluation that the vena seal device caused the reactions seen.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: no challenges or deviations related to location of catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to sfj.The issue is still ongoing.At this time, the nodules around the legs are not creating any pains or infection.There has been some improvement around the wounds around the nodules noticed, therefore, the physician is monitoring the patient further to see if patient will gradually improve.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: 16751142
• MDR Text Key: 313415294
• Report Number: 9612164-2023-01632
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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: 04/22/2023
• 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; Hospitalization
• Patient Sex: Male