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

Model Number	VNMC4034C200TU
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: v nmc4337c200tu, serial/lot #: (b)(6), ubd: 27-feb-2021, udi#:(b)(4) ; product id: vnmc4034c200tu, serial/lot #: (b)(6), ubd: 03-sep-2021, 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 or Problem Description
A valiant navion stent graft (vnmc4034c200tu) was implanted during the endovascular treatment of a thoracic aortic dissection 2 additional valiant navion stent grafts (vnmc4337c200tu & vnmc4034c200tu) were implanted 18 months later.It was reported under four years later, a follow up ct showed a seam separation(s) in the valiant navion stent grafts.It is unknown which navion graft is affected.Intervention was performed where the grafts were relined with non-mdt stent grafts.The patient is reported as doing fine post intervention.Per the physician the cause of the stent graft separation is undetermined.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
B5: additional information received.Corelab review of ct imaging from 5 years, after the index procedure, identified a type iiib endoleak associated with devices vnmc4034c200tu ((b)(6)) and vnmc4337c200tu ((b)(6)).Stent fracture was observed, on stent rings 7 and 8 on device vnmc4034c200tu ((b)(6)).Stent ring enlargement was noted, on stent ring 4 (+2.4), stent ring 7 (+6.7), stent ring 8 (+8.0) on vnmc4034c200tu ((b)(6)).And on stent ring 3 ( +2.6) on vnmc4337c200tu ((b)(6)).No stent migration was observed.The maximum aortic enlargement was 85.8mm.The imaging was noted, as not assessable for aneurysm enlargement.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
• Common Device Name: 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: 19161845
• Report Number: 9612164-2024-01938
• Device Sequence Number: 7349704
• Product Code: MIH
• UDI-Device Identifier: 00763000101251
• UDI-Public: 00763000101251
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2021
• Device Model Number: VNMC4034C200TU
• Device Catalogue Number: VNMC4034C200TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 04/29/2024
• Date Device Manufactured: 01/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male