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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Phlebitis (2004); Thrombosis/Thrombus (4440)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Medtronic received a journal article titled 'case of resection of phlebitis in an untreated branch after endovascular embolization of lower extremity varices' reporting a venaseal case.A patient was treated with venaseal in the great saphenous vein (gsv) on an unknown date in 2021.The ifu had been followed. ultrasound-guided gsv puncture at 10 cm below the knee under local anesthesia.A 7 fr pair of sheath was inserted into the gsv.Placed the catheter tip 5 cm distal to the sapheno-femoral junction (sfj) and performed cac.The treatment length was 31 cm and the injection volume of cyanoacrylate was 1.2 ml.The ultrasound examination at the end of the surgery, showed the blood flow in the gsv at the site of cac had ceased, and the distance from the site of embolization by glue to the sfj was maintained at 5 cm.One week after surgery, a rubefaction 2 cm large in diameter was palpable on the center of the inner thigh, and there was a complaint of pain in the same area.No itching, no systemic symptoms such as fever or urticaria on thetrunk were observed.The induration coincided with the site of the superficial varicose vein of the gsv branch confirmed prior to the surgery.Postoperative ultrasonography examination findings: the gsv main trunk was filled with glue, blood flow was interrupted, and no inflammation was observed in the surrounding area.A superficial vein in the central thigh branching from the main trunk of the gsv had a continuous inflow of glue from the main trunk of the gsv, and the superficial varicose vein was filled with glue and the vein wall and surrounding tissue showed increased brightness.Based on ultrasonographical findings, a diagnosis of phlebitis of the gsv branch was made, and was treated with non-steroidal anti-inflammatory drugs (nsaids) and followed up for approximately 2 weeks.However, the pain did not improve and the inflammatory findings persisted, so extraction surgery was performed.Surgical findings: under local anesthesia, a 2 cm incision was made just above the induration site.Veins and soft tissue affected by inflammation were removed.The extracted specimen had a length of 3 cm, inflammatory thickening of the resected vein wall was observed, but thrombus formation within the lumen was slight.

• 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: 16616571
• MDR Text Key: 312013306
• Report Number: 9612164-2023-01262
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2023
• 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