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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Fever (1858); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Skin Inflammation (2443); Skin Inflammation/ Irritation (4545)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Venaseal was used for treatment of the patient¿s great saphenous vein (gsv) as per ifu for c6 disease with persistent weeping and a history of recurrent statis ulceration.The patient is reported to have had significant saphenous reflux.A guidewire was used for insertion of the catheter.69cm of vein was treated, using a total of 2.3cc of cyanoacrylate adhesive.The vein is reported to have closed, with adequate closure achieved throughout the length and patency of the saphenofemoral junction for about 4cm with patency of the superficial epigastric vein also.The patient is reported to have tolerated the procedure well.The patient was kept on anticoagulation and there was no significant bleeding.The patient was due to return for standard one-week duplex surveillance.It is reported 2 days post venaseal implant the patient was admitted to hospital with hypertension, fever, and erythema near the access site.The patient was started on antibiotics and released from the hospital within a day or two.Two weeks later the patient was readmitted to the hospital with pus coming out of the access site and some adhesive particles were extracted at the site as well.The patient was again treated for infection with antibiotics.A second wound developed a few centimetres above the access site extruding some pus and glue also.Ultrasound exam revealed a normal closed vein throughout the thigh and lower leg.A complex, possibly fluid containing mass was identified in the distal thigh which potentially could be an infected fluid collection.The physician did not feel concerned that this mass could be a foreign body granuloma and considered fine needle aspiration of some fluid during the patient¿s n ext visit.The patient returned for wound care and pseudomonas bacteria was present in the fluid taken from the wound.The original venous statis wound is reported to have healed.The patient will return for regular follow-up.No further injury reported.

Manufacturer Narrative

Photo analysis: the customer provided a photo of the patient's leg where redness was found on two locations.I tis possible the would may show signs of infection.One of the areas of redness was likely the access site.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
• MDR Report Key: 10815620
• MDR Text Key: 215473351
• Report Number: 9612164-2020-04340
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 113