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

Catalog Number VS-403

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vasoconstriction (2126); Thrombosis/Thrombus (4440)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

On (b)(6) 2024 a physician used a venaseal closure system during patient treatment.The ifu (instruction for use) was followed during catheter preparation, procedure, post-procedure.The catheter lumen was flushed prior to use.A guidewire was used during catheter insertion and placement.A spasm was formed up to sapheno-femoral junction (sfj), and the blood vessel diameter was narrow.Treatment was performed at a distance of 5 cm according to ifu.After the treatment, it was observed that the glue had extended to femoral vein (fv) when checked with the echocardiogram.Approximately egit class 3 was reported.Precautions were taken, and at the time of the day trip, hospitalization was done and patient was kept under observation.On the following day, a thrombosis was observed around the extended glue, so on (b)(6) 2024 the extended thrombus was ligated under general anesthesia and the thrombus removed.

Manufacturer Narrative

Additional information: compression of the gsv was applied.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VENASEAL 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: 19039822
• MDR Text Key: 339322972
• Report Number: 9612164-2024-01596
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-403
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• 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; Required Intervention