MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number VNMC4040C218TJ

Device Problem Leak/Splash (1354)

Patient Problem Rupture (2208)

Event Date 03/31/2024

Event Type  Injury  

Manufacturer Narrative

Concomitant products: information references the main component of the system.Other relevant device(s) are: product id: v nmc4343c175tj, serial/lot #: (b)(6), ubd: 01-apr-2022, udi#: (b)(4).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

Valiant navion stent grafts were implanted during the endovascular treatment of a thoracic aortic aneurysm.Prior to the implant of the navion grafts a 2 debranching, brachiocephalic chimney (non mdt stent) in zone 0 was performed.Two non mdt were placed.It was reported after the initial implantation no endoleaks were observed and no further follow up.It was reported approximately 4 years post the index procedure, the patient presented emergently due to chest rupture.A type iii endoleak was suspected.Emergency tevar was performed, and a non-mdt stent graft was used to reline.The patient progress was noted as good.Per the physician the cause of the rupture and endoleak is undetermined.No additional clinical sequalae were provided and the patient will be monitored.

Manufacturer Narrative

Additional information received: it could not be determined if the endoleak was a type iiib hole/tear or a type iiia separation between the grafts.The additional graft implanted resolved the rupture.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.

Manufacturer Narrative

B5; additional information received: it was reported that the devices were implanted in the following order: vnmc4343c175 proximal and vnmc4040c218 distal.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.

Manufacturer Narrative

B5; additional information received : corelab reviewed ct imaging dated the (b)(6) 2024.No endoleak or fracture was noted.The following new stent ring enlargements were noted on the stent graft (b)(6); +4.9mm on ring 6, + 2.2mm on ring 7, +1.7mm on ring 5.Stent ring migration of + 2.5mm on ring 6 in stent graft (b)(6) was also observed.The max aortic diameter of 79.0mm with an aortic enlargement of + 10.1mm in comparison to imaging dated (b)(6) 2020.Corelab reviewed ct imaging dated the (b)(6) 2024.No endoleak or fracture was noted.The following persistent stent ring enlargements were noted on the stent graft (b)(6); +4.2mm on ring 6, + 2.1mm on ring 7, +1.7mm on ring 5.Stent ring migration of + 3.3 mm on ring 6 on the stent graft (b)(6) was also observed.The max aortic diameter of 81.6 mm with a persistent aortic enlargement of + 12.7mm in comparison to imaging dated (b)(6) 2020.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: VALIANT NAVION
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 19095393
• MDR Text Key: 340001007
• Report Number: 9612164-2024-01771
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100040
• 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,Followup
• Report Date: 05/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: VNMC4040C218TJ
• Device Catalogue Number: VNMC4040C218TJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/18/2024; 05/21/2024
• Supplement Dates FDA Received: 04/22/2024; 05/22/2024
• Date Device Manufactured: 04/01/2020
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention