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

Model Number VNMC4034C200TU

Device Problems Fracture (1260); Leak/Splash (1354); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2024

Event Type  Injury  

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 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.

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
• 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: 19161845
• MDR Text Key: 340791881
• Report Number: 9612164-2024-01938
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000101251
• UDI-Public: 00763000101251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 04/29/2024
• Date Device Manufactured: 01/09/2019
• 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
• Patient Age: 63 YR
• Patient Sex: Male