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

Model Number	VNMC4646C218TU
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582); Aneurysm expansion (4597)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Valiant navion stent grafts were implanted during the endovascular treatment of a thoracic aortic aneurysm.It was reported core lab review of ct imaging from approx.48 months post index procedure, noted a new stent ring enlargement of + 1.5mm was noted on ring 4 of (b)(6) and +1.6mm on ring 6 of(b)(6).A new type iiib endoleak observed on stent graft (b)(6).No fracture or stent ring migration were noted.The maximum aortic diameter measured 58.5mm.No aortic enlargement was reported.No stent ring migration or stent fractures were observed.No additional clinical sequalae were provided and the patient will be monitored.
Additional 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.
Additional Manufacturer Narrative
Additional information received; it was reported that a secondary procedure was performed approximately 5 years post-index procedure to treat the type iiib endoleak.The valiant captivia was relined with one 45 x 10 cm and two 45x 20 cm non-medtronic stent grafts.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.
Additional Manufacturer Narrative
Additional information received: corelab review of ct scans performed approximately 4 years and 10 months after the index procedure identified a type iiib endoleaks associated with vnmf4343c223tu and a type iiib endoleak in vnmc4646c218tu stent graft.Stent ring enlargement in vnmf4343c223tu was noted as follows: +2.4mm at ring 3 (persistent), +3.0mm at ring 6 (new).For vnmc4646c218tu, stent ring enlargement was observed at: +3.9mm at ring 6 (persistent), +2.7mm at ring 5 (new), +4.1mm at ring 7 (new), +3.0mm at ring 8 (new), +3.8mm at ring 11 (new), and +1.8mm at ring 12 (new).No stent fractures were identified.Aortic enlargement of +5.3mm was observed compared to imaging from approximately 10 months post-index procedure.Dissection was also identified within the distal navion stent vnmc4646c218tu.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.
Additional Manufacturer Narrative
The valiant navion stent grafts were relined with one 45 x 10 cm and two 45x 20 cm non-medtronic stent grafts.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.
Additional Manufacturer Narrative
Additional information received: corelab review of ct imaging performed approximately 5 years and 1 month post-index procedure identified persistent stent ring enlargement on stent graft vnmf4343c223tu (+1.8 mm at ring 3 and +2.8 mm at ring 6).Persistent stent ring enlargement was also observed on stent graft vnmc4646c218tu (+2.8 mm at ring 6, +1.8 mm at ring 5, +2.8 mm at ring 7, +1.8 mm at ring 8, +2.7 mm at ring 11, and +1.7 mm at ring 12).Persistent aortic enlargement of +5.6 mm was noted when compared to ct imaging obtained approximately 11 months post-index procedure , with a maximum aortic diameter of 62.1 mm.No endoleak or stent fracture was observed in the devices.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: 21738599
• Report Number: 9612164-2025-01635
• Device Sequence Number: 4007782
• Product Code: MIH
• UDI-Device Identifier: 00763000101190
• UDI-Public: (01)00763000101190(17)210101(21)V08195399
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/12/2025

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: 01/01/2021
• Device Model Number: VNMC4646C218TU
• Device Catalogue Number: VNMC4646C218TU
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 10/13/2025; 11/07/2025; 11/19/2025; 12/12/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/15/2025; 10/29/2025; 11/10/2025; 11/21/2025; 12/12/2025
• Date Device Manufactured: 01/02/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005364322-02-19-2021-00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Female