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

Model Number VS-404

Device Problem Biocompatibility (2886)

Patient Problems Extravasation (1842); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used the venaseal closure system to treat the patient's great saphenous vein (gsv).Local anaesthesia was used.The lumen was flushed prior to use.The procedure was completed per ifu.Both gsv's were treated.No challenges or deviation related to the location of the catheter tip prior to the initial delivery of adhesive.The catheter tip was 5 cm caudal to sfj.Compression was used.However, the adhesive was delivered every 4cm rather than 3cm due to the superficial nature of the gsv and the physician's medical judgement.The vein did close.It was reported that there was chronic venaseal extravasation/foreign body reaction along the course of the gsv.The patient's symptoms associated with this event also included pain and inflammation.The first symptoms occurred approximately 6 weeks post treatment of the right gsv (2.5 weeks post treatment of the left gsv) with erythematous rash reported below the knee along the course of the vein.Lot of pain were reported over the past few days.Patient was not compliant with benadryl or anti-inflammatory medication suggested.There was one spot on the skin, which appeared to have a little bit of excoriation, but there was no skin breach.Benadryl and aleve, or ibuprofen, were suggested round-the-clock for the next couple days.Four days post onset of symptoms, improvement was seen with benadryl and nsaids.Pain and skin problems resolved per patient, with cord along superficial vein still noted.Physician suggested to continue with benadryl and nsaids as needed for a few more days.14 days later patient again showed bead-like cord reaction along the course of the gsv bilaterally.A start of metoprolol succinate er tablet extended release 24-hour, 50 mg, 1 tablet, orally, once a day, so days, refills 3, low salt diet.Approximately one week later, patient calls the office and states that the veins are erupting/bursting and needs to be seen soon.Patient is seen in the office for swelling in the legs, vein bursting, and pus noted along areas of the gsv bilaterally.Patient was to start minocycline 100 mg, 1 capsule orally every 12 hours for 10 days and prednisone 200 mg, 1 tablet orally, once a day for five days.The patient was referred to an infectious disease expert physician and another physician for further consult and treatment plan.Approximately two weeks later, nodular areas along the vein seem to be drying out with medication and sterile dressings.Patient was scheduled for a biopsy; however, the patient missed the appointment due to the patient's thoughts that the wounds were healing with medications.However, after completion of the medications, a couple of the nodular areas began to emit puss-like drainage.The original physician, the physician for the biopsy, and the infectious disease expert physician continued care by prescribing batrim ds bid-10 days and encouraged the patient to have a biopsy done, even if the wounds appeared to be healing.Two bilateral sites in the medial thigh area, 3-4 cm above the knee, were cleaned and dressed in bioclusive dressings.10 days later, one open lesion with purulent was noted on the left thigh and multiple other granulomatous nodules were noted along the course of the bilateral gsv.Patient remains on the bactrim.No steroids prescribed at this time.Right mid-thigh and below knee biopsy sites healed well.Currently awaiting biopsy and discussion with the physician for the biopsy and the disease expert physician for further treatment plan.The issue is still present.No further patient injury reported.

Manufacturer Narrative

Image analysis seven image files were returned for review, the images were provided: from the images provided the patient is showing a bead-like cord reaction along the course of the gsv bilaterally and the presence of granulomatous nodules with one of the images showing one open lesion with purulent which is noted on the left thigh consistent with the reported event.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: 14139813
• MDR Text Key: 289511074
• Report Number: 9612164-2022-01484
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: 00763000240776
• 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: 05/24/2022

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
• Device Expiration Date: 07/31/2023
• Device Model Number: VS-404
• Device Catalogue Number: VS-404
• Device Lot Number: 64472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 05/24/2022
• Date Device Manufactured: 07/13/2021
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 63 KG