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

Catalog Number SP-101

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Ulceration (2116)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

Image review: six photographic images were received for analysis.The first two images are of the patient¿s right leg upper calf at the access site.Both images show an ulcer surrounded by erythema, (redness) and eschar (scabbing).The second image is taken at a different angle from the first image.The third image is of the patient¿s right leg thigh.Scattered erythema and small pustules, (blisters with puss), are visible along the treated vessel.The fourth image is of the patient¿s right hip/groin area.Scattered erythema and small pustules, (blisters with puss), are visible along the treated vessel.The fifth and sixth images are duplicates of each other.They are images of the procedural notes which show the planned treatment of the vessels in both the right and left leg.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient had the great and small saphenous veins of both legs treated with venaseal occluding device.Lumen was flushed prior to use.Ifu was followed.A guidewire was used for insertion of the catheter.The procedure was completed as normal and the veins were reported to have closed.48ml of adhesive were used to treat both legs.Protocol for treatment of both legs was identical.It was reported that 12 days after the treatment, the patient mentioned burns and redness at the lower right leg at the access point.The lesions were treated with ethanol bandages due to the redness and foreign body reaction.After approximately 9 days, the patient presented 2 perforated tension-blisters and pustules on both legs and the torso, starting from the lower leg.The patient reported no pain.The ulcers on the left leg was reported to be healing.Patient was not given drug therapy.An ethanol dressing was applied after 12 days due to redness and foreign body reaction.The existing ulcers on the right leg heals continuously.An allergy is reported to have occurred after 21 days, starting from the right lower leg.Tension bubbles were already open at re-presentation.No information available regarding possible wound dressings or anointing.The patient has been hospitalized due to angitis of unknown etiology, but this was deemed as not allergy related.There was no further patient injury reported for this event.

Manufacturer Narrative

Additional information: the patient has left the hospital after 4 days in good condition.No allergy was diagnosed.The patient has leukocytosis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: journal title: saphenion science - vein glue allergy is there a significant risk journal: journal of phlebology and lymphology year: 2020 ref: doi: (b)(6) 62 patient had the small saphenous vein (ssv) and great saphenous vein (gsv) of both legs treated in the same procedure.Bilateral gsv and ssv were considerably refluxive and expanded.There was marked tissue edema on both lower legs, the skin showed traces of chronic inflammation and recurrent soft tissue inflammation was noted prior to venaseal treatment.The follow-up examinations by means of clinical examination and duplex ultrasound showed a clear decrease in soft tissue swelling and venous pressure in the lateral veins.The existing ulcer on the left lower leg was already smaller and showed a clean wound area with a clear tendency to heal.The ultrasound examination confirmed that all 4 varicose veins were almost completely closed.Micro foam therapy for side branches varicose veins was then started 14 days later.We first treated the left leg to further accelerate the healing of the ulcer.Another 14 days later the patient turned acute with a massive inflammatory reaction on the right lower leg in front.Inflammatory ca pillary bleeding and pustules were visible on both legs and the upper body the patient was admitted to a university clinic on suspicion of a cyanoacrylate allergy after venaseal® therapy.The inpatient stay lasted 6 days.Leukocytoclastic vasculitis (leukocyte-reactive capillary inflammation) was diagnosed.Tissue removal then showed suspicion of leukocytoclastic vasculitis of parainfectious genesis due to erysipelas on the right lower leg.The therapy consisted of cooling, anti-inflammatory bandages on the vasculitis areas, and lavanide gel as well as fatty gauze for the ulcer.Antibiotic therapy was also carried out.The duplex sonographic diagnosis of the leg veins showed no further evidence of persistent chronic venous insufficiency.The treated varicose veins were effectively closed. in the meantime micro foam therapy on the right leg was continued, the ulcer on the left lower leg has become significantly smaller.A new ulcer has now formed on the right lower leg in the area of erysipelas.Evidence of an allergy to the vein glue venaseal® could not be provided.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.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9971472
• MDR Text Key: 189905192
• Report Number: 9612164-2020-01598
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 54796
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR