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

Device Problem Biocompatibility (2886)

Patient Problems Ecchymosis (1818); Granuloma (1876); Phlebitis (2004); Skin Discoloration (2074); Insufficient Information (4580)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

Title: nonthermal and nontumescent treatment of saphenous vein insufficiency¿early results with ifu-conform and modified use of the venaseal¿ closure system author: richard brandl journal: gefässchirurgie year: 2022 vol/issue: 27 ref: 10.1007/s00772-022-008.Event date: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study which aims to explore technical standards for vein diameters >6 mm at the saphenofemoral junction (sfj) for treatment with venaseal.303 patients (404 veins) were included in the study.45 patients (60 veins) were treated with venaseal according to the manufacturers ifu.In 258 patients with 340 varicosities the glue was applied in a modified technique according to a graduated protocol for unselected diameters from 3¿17.8mm.For larger vein diameters, the position of the proximal catheter tip distal to the sfj was shortened stepwise up to 2 cm along with elevating the number of releasing points within the first 5 cm from 2 to 5 with doses of 0.09 ml or 0.18 ml glue.Technical success was achieved in 399/400 patients (99.8%).Following the ifu-conform run-in phase, most treated veins exceeded 6 mm in sfj-near diameter.Phlebitis of truncal veins or side branches, ecchymoses and transient pigmentation were rare in both groups.There was one proximal accidental glue extension (page) (non-int ended presence of glue outside the treatment zone, i.E.Beyond the sapheno-femoral junction) in both groups, which were transient and without thrombus formation.

Manufacturer Narrative

Additional information: the patient for which the procedure was not successful was treated with ugfs.A granuloma is reported for one patient on the basis of an extravasal placement of an adhesive particle in subcutaneous tissue at the puncture site.Venous thromboses, nerve lesions, lymph vessel complications were not observed.Transient erythema in the magna area on the thigh appeared in the initial phase more frequently than with the consecutive use with physical prophylaxis.The intervention related morbidity after 6 and 12 weeks was overall 1.0 and 0.25%, respectively.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: 14141360
• MDR Text Key: 289508606
• Report Number: 9612164-2022-01503
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• 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): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male